Reports for Product Code DZN
Description of Event or Problem: In this event it is reported that palodent plus univ 2 ring ref broke during use. No injury occurred.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21 cfr part 803. The device is available for evaluation, though has not been...show all
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. as such, this event is reportable...show all
Description of Event or Problem: In this event it is reported that palodent v3 univ 2 ring refil broke during use. The outcome of this event is unknown as of this mdr.
Description of Event or Problem: In this event it is reported that a automatrix shaft broke during use. No injury occurred.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Additional Manufacturer Narrative: A capa was opened and investigated. Since 1/1/2023, there have been 153 substantiated complaints for broken automatic shafts. Based on the contributing factors identified through root cause analysis, the overall root cause is the variation of product quality by inconsistent build techniques interpreted by the current work instructions and measuring...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though results are not available...show all
Description of Event or Problem: In this event it is reported that a automate iii broke during use. No injury.
Description of Event or Problem: Fracture of driver
Additional Manufacturer Narrative: The doctor presented a complaint in malfunction of a driver fractured when connected to dental implant. The implant had to be removed and replaced. No further complications were reported. Manufacturer's trend analysis show that malfunction of drivers is a low-rate adverse event.
Description of Event or Problem: In this event it is reported that palodent 360 6.5mm rf broke during use.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was not returned for evaluation. However, the lot number was provided and...show all
Description of Event or Problem: In this event it is reported that a automatrix shaft broke during use. No injury.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Additional Manufacturer Narrative: Investigation: product not received as of yet, lot number unknown. Unsuccessful attempts to retrieve suspect product for investigation/evaluation have been made and documented. Complaint will be reopened if suspect product or investigation result arrives per 8000-sop-038.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it is reported that a palodent v3 univ 2 ring refil broke during use.
Description of Event or Problem: No primary stability of the dental implant 3 months after placement, pain.
Additional Manufacturer Narrative: Investigation results: 11-7-2024: returned product 1 triodent v3 ring narrow yellow (older v3 design) broken in half a the pivot point. Overmolding date codes verified ¿d¿ for april and ¿i¿ for 2019. The returned product was produced 04-2019 which exceeds the 2 year useful life as per attached rationale email...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it is reported that v3 ring narrow (yellow) 2 pack broke during use. No injury occurred.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it is reported that automatrix refill med thin broke during use.
Additional Manufacturer Narrative: Returned product 1 unit item# 663001 automatrix refill med thin lot# 07247723 with only 8 of the original 72 bands within the original packaging carton. The problem "the bands will tear during use" could not be duplicated to the retained bands returned by using standard testing protocol on all 8...show all
Description of Event or Problem: In this event, it is reported. That automatrix shaft broke, during use.
Additional Manufacturer Narrative: While no serious injury resulted in this event. If this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable, per 21 cfr part 803. The device is available for evaluation. Though, results are not...show all
Additional Manufacturer Narrative: Returned product was 1 flexshaft date code 1023 with coil deformation/weld failure causing the product to not function properly. Capa-2023-519 opened to address automatrix flexshaft assemblies breaking for product manufactured by sarasota since september 2022 (date code 0922) through implementation date of (b)(6) 2024 (date code 0524). Complaint is considered...show all
Additional Manufacturer Narrative: Returned product was 1 automate iii tightening device and 1 flexshaft assembly date coded 0224 with coil deformation/weld failure causing the product to not function properly. Capa-2023-519 opened to address automatrix flexshaft assemblies breaking for product manufactured by sarasota since september 2022 (date code 0922) through may 2024 (date code...show all
Description of Event or Problem: In this event it is reported that automate tool refill broke during use. No injury.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Description of Event or Problem: In this event it is reported that automatrix shaft broke during use.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Additional Manufacturer Narrative: On 9-10-2024: returned product was 1 flexshaft assembly date coded 0723 with coil deformation/weld failure causing the product to not function properly. Capa-2023-519 opened to address automatrix flexshaft assemblies breaking for product manufactured by sarasota since september 2022 (date code 0922) through may 2024 (date code 0524). Complaint is considered...show all
Description of Event or Problem: In this event it is reported that v3 ring narrow (yellow) 2 pack broke during use. No injury.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Additional Manufacturer Narrative: Failure mode - broken product. Root cause - not determined. Conclusion code - indeterminable. 10-21-2024: dhr for item# 403343 batch# 07150828 has been pulled, reviewed, and attached to this case. Dhr review did not indicate any production issues while packaging/labeling the v3 ring narrow (yellow) 2 pack. Work order (b)(4)...show all
Additional Manufacturer Narrative: Returned product was 1flexshaft date code 1223 with coil deformation/weld failure causing the product to not function properly. Capa-2023-519 opened to address automatrix flexshaft assemblies breaking for product manufactured by sarasota since september 2022 (date code 0922) through implementation date of may 2024 (date code 0524). Complaint is considered substantiated....show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it is reported that a automatrix shaft broke during use. No injury occurred.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though results are not available...show all
Description of Event or Problem: In this event it is reported that a palodent v3 univ 2 ring refil broke during use. No injury.
Additional Manufacturer Narrative: Device was evaluated and the ring is broken. Unable to investigate further because the lot number is unknown.
Description of Event or Problem: In this event it is reported that an automatrix shaft tip broke during use. No injury.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though results are not available...show all
Additional Manufacturer Narrative: Returned product was 2 flexshaft assemblies date coded 1022 & 1122 with coil deformation/weld failure causing the product to not function properly. Capa-2023-519 opened to address automatrix flexshaft assemblies breaking for product manufactured by sarasota since september 2022 (date code 0922) through may 2024 (date code 0524). Complaint is considered...show all
Additional Manufacturer Narrative: The doctor presented a complaint on tool unp 2mm hex handpiece adapter - long, fractured when conected to dental implant . Despite that no patient complications were reported, it could have caused or contributed to a serious injury or require medical or surgical intervention to prevent it. As such,...show all
Description of Event or Problem: Fracture of driver.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Description of Event or Problem: In this event it is reported that a palodent v3 univ 2 ring refil broke during use. No injury occurred.
Additional Manufacturer Narrative: Returned product 1 v3 universal palodent ring (new and improved design v5) with 1 of the tynes broken off/missing from one side of the ring. Overmolding date codes ¿g¿ for july and ¿n¿ for 2022. Returned product does not meet specifications, final packaging product retains are not kept as per...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though results are not available...show all
Description of Event or Problem: In this event it is reported that a automate iii broke during use. No injury.
Additional Manufacturer Narrative: The doctor presented a complaint in malfunction of rs hex hand piece adapter long that fractured when conected to dental implant. Despite that no patient complications were reported, it could have caused or contributed to a serious injury or require medical or surgical intervention to prevent it. As such, this...show all
Description of Event or Problem: Fracture of driver.
Additional Manufacturer Narrative: The doctor presented a complaint on fracture of rs hex hand piece adapters rs9029 lot 7560308 and rs9026 lot 7655315, that fractured during sterilization cycle. Despite that no patient complications were reported, it could have caused or contributed to a serious injury or require medical or surgical intervention to prevent...show all
Description of Event or Problem: Fracture of driver.
Additional Manufacturer Narrative: The doctor presented a complaint on tool gs0017 that fractured trying to correct the placement of a dental implant . Despite that no patient complications were reported, it could have caused or contributed to a serious injury or require medical or surgical intervention to prevent it. As such, this...show all
Description of Event or Problem: Fracture of driver.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it is reported that a automate iii broke during use. Tip broke during tightening.
Additional Manufacturer Narrative: Returned product was 1 flexshaft date code 0223 with coil deformation/weld failure causing the product to not function properly. Capa-2023-519 opened to address automatrix flexshaft assemblies breaking for product manufactured by sarasota since september 2022 (date code 0922) through implementation date of may 2024 (date code 0524). Complaint is considered...show all
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Description of Event or Problem: In this event it is reported that a palodent v3 narrow 2 ring refl broke during use. The outcome of this event is unknown as of this mdr. Further information requested.
Additional Manufacturer Narrative: Returned product 1 palodent narrow dark blue v3 ring (new and improved v5 version) with 2 broken tynes. Overmolding date codes verified ¿f¿ for june and ¿n¿ for 2022. Final packaging product retains are not kept as per normal procedure. Ring over-molding retains were reviewed and meet all inspection and...show all
Additional Manufacturer Narrative: Investigation results: ring is broken - fail ; failure mode: broken product; root cause: not determined; conclusion: indeterminable.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Description of Event or Problem: In this event it is reported that a palodent v3 narrow 2 ring refl broke during use.
Additional Manufacturer Narrative: Investigation results: return 7-23-2024: product not returned, however image in case depicts 1 v3 ring universal blue (new and improved design v5) with 1 of the tynes broken off. Overmolding date codes are not visible with provided image. Dhr and retain evaluation will be conducted. (nwv). Retain 7-23-2024: final packaging...show all
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Description of Event or Problem: In this event it is reported that a palodent v3 univ 2 ring refil broke during use.
Description of Event or Problem: In this event it is reported that an automate iii broke during use. No injury.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though results are not available...show all
Additional Manufacturer Narrative: Return: (b)(6) 2024: returned product was 1 flexshaft assembly date coded 0224 with coil deformation/weld failure causing the product to not function properly. Capa-2023-519 opened to address automatrix flexshaft assemblies breaking for product manufactured by sarasota since (b)(6) 2022 (date code 0922) through (b)(6) 2024 (date code 0524). Complaint is...show all
Additional Manufacturer Narrative: The doctor presented a complaint on a fractured rs hex handpiece adapter. Despite that no patient complications were reported, it could have caused or contributed to a serious injury or require medical or surgical intervention to prevent it. As such, this event is reportable per 21 cfr part 803. In...show all
Description of Event or Problem: Fracture of driver.
Additional Manufacturer Narrative: Return: returned product 1 automate iii tightening device and 1 automatrix flexshaft date coded 1023 with weld failure/coil deformation resulting in the ¿tip¿ breaking off. Capa-2023-519 opened to address flexshaft failures for product manufactured by sarasota since september 2022 (date code 0922) through may 2024 (0524). Dhr review and retain...show all
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Description of Event or Problem: In this event it is reported that a automate iii broke during use. The outcome of this event is unknown as of this mdr. Further information requested.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it is reported that automatrix shaft broke during use.
Additional Manufacturer Narrative: Returned product was 1 flexshaft date code 1223 with coil deformation/weld failure causing the tip to break off rendering the product to not function properly. Capa-2023-519 opened to address automatrix flexshaft assemblies breaking for product manufactured by sarasota since september 2022 (date code 0922) through implementation date of may 2024...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it is reported that automatrix shaft broke during use. No injury.
Additional Manufacturer Narrative: Returned product was 1 flexshaft date code 0621 with coil deformation/weld failure causing the product to not function properly. Capa-2021-375 opened to address weld failures for product manufactured by sarasota since december 2020 (date code 1220) through implementation date of august 2022 (0822). Note the flexshaft was produced in 06-2021...show all
Additional Manufacturer Narrative: The doctor presented a complaint in malfunction of rs hex hand piece adapter long that fractured when connected to dental implant isf1050 lot 7763317 at the implantation surgery. The implant was replaced by another similar one. Despite that no patient complications were reported, it could have caused or contributed to...show all
Description of Event or Problem: Fracture of driver.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though results are not available...show all
Description of Event or Problem: In this event it is reported that automatrix shaft broke during use. No injury.
Additional Manufacturer Narrative: 6-17-2024: returned product was 1 flexshaft assembly date coded 0623 with coil deformation/weld failure causing the product to not function properly. Capa-2023-519 opened to address automatrix flexshaft assemblies breaking for product manufactured by sarasota since september 2022 (date code 0922) through may 2024 (date code 0524). Complaint is considered substantiated...show all
Additional Manufacturer Narrative: Investigation results: return: 5-2-2024: product not returned; image in case depicts 1 palodent v3 narrow/dark blue ring (new and improved design v5) with a broken tyne. Over-molding date codes confirmed ¿b¿ for february and ¿n¿ for 2022. Product does not meet specifications, dhr and retain evaluation will be conducted. (nwv)....show all
Description of Event or Problem: In this event it is reported that a palodent v3 univ 2 ring refil broke during use. No injury occurred.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device was not returned for evaluation. However, the lot number...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. this event, therefore, is reportable per 21cfr part 803.the device is available for evaluation, though results are not available...show all
Description of Event or Problem: In this event it is reported that automatrix shaft broke during use. No injury.
Additional Manufacturer Narrative: Investigation results 5-22-2024: returned product 2 flexshafts date coded 0523 & 1023 with coil deformation/weld failure resulting in the device to not function properly. Capa-2023-519 opened to address flexshaft failures for product manufactured by sarasota since september 2022 (date code 0922) through present day. Item# 62422603 batch# 07790394 utilized item#...show all
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Description of Event or Problem: In this event it is reported that v3 ring mixed 2 pack broke during use. The outcome of this event is unknown as of this mdr.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Description of Event or Problem: In this event it is reported that palodent plus pin tweezers - the prong broke off of the new palodent tweezers. No injury occurred.
Additional Manufacturer Narrative: Investigation return 5-9-2024: returned product 1 pair of palodent plus pin tweezers item# 759820 batch# 100322 was inspected and confirmed to be missing the ¿pin¿ at the tips of the tweezers which aids in holding the tab matrices in place within the instrument. The returned product is not to specification...show all
Additional Manufacturer Narrative: The doctor presented a general complaint in malfunction of unifit star torque drivers and handpieces. A fractured handpiece uf0071 was returned. Despite that no patient complications were reported, it could have caused or contributed to a serious injury or require medical or surgical intervention to prevent it. As such, this...show all
Description of Event or Problem: Fracture of driver.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Description of Event or Problem: In this event it is reported that palodent v3 univ 2 ring refil broke during use.
Additional Manufacturer Narrative: Failure mode: broken product. Root cause: no defect proven. Conclusion code: no failure found. 6-4-2024: dhr for item# (b)(4) batch# 06616069 has been pulled, reviewed, and attached to this case. Dhr review did not indicate any production issues while packaging/labeling the palodent v3 univ 2 ring refill. Work order (b)(4)...show all
Additional Manufacturer Narrative: While there has been no information received that the patient was injured, ingestion can lead to a possibility of surgical intervention to remove the swallowed piece. Therefore, this event is reportable per 21 cfr part 803. The device was not returned for evaluation and the lot number was not provided...show all
Description of Event or Problem: In this event it is reported that palodent v3 narrow 2 ring refl was ingested by a patient. The practice reports that the patient is fine. The patient will be referred for an x-ray. The outcome of this event is unknown as of this mdr. Further information requested.
Description of Event or Problem: In this event it is reported that automatrix extra shaft assy broke during use. No injury.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though results are not available...show all
Additional Manufacturer Narrative: Returned product was 1 flexshaft date code could not be verified as the base of the flexshaft where the date code is stamped and the base is crimped to the flex sleeve is broken off/missing. Capa-2023 opened to address automatrix flexshaft assemblies breaking for product manufactured by sarasota since september...show all
Description of Event or Problem: Malfunction of driver.
Additional Manufacturer Narrative: The doctor presented a general complaint in malfunction of unifit star torque drivers (uf0066 and uf0067). Despite that no patient complications were reported, it could have caused or contributed to a serious injury or require medical or surgical intervention to prevent it. As such, this event is reportable per 21cfr...show all
Additional Manufacturer Narrative: The doctor presented a general complaint in malfunction of unifit star torque drivers (uf0066 and uf0067). Despite that no patient complications were reported, it could have caused or contributed to a serious injury or require medical or surgical intervention to prevent it. As such, this event is reportable per...show all
Description of Event or Problem: Malfunction of driver.
Description of Event or Problem: Malfunction of driver.
Additional Manufacturer Narrative: The doctor presented a general complaint in malfunction of unifit star torque drivers (uf0066 and uf0067). Despite that no patient complications were reported, it could have caused or contributed to a serious injury or require medical or surgical intervention to prevent it. As such, this event is reportable per 21cfr...show all
Description of Event or Problem: Malfunction of driver.
Additional Manufacturer Narrative: The doctor presented a general complaint in malfunction of unifit star torque drivers (uf0066 and uf0067). Despite that no patient complications were reported, it could have caused or contributed to a serious injury or require medical or surgical intervention to prevent it. As such, this event is reportable per...show all
Description of Event or Problem: In this event it is reported that palodent v3 univ 2 ring refil broke during use. No injury.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device was not returned for evaluation and the lot number...show all
Additional Manufacturer Narrative: Investigation: failure mode: broken product. Root cause: not determined. Conclusion code: indeterminable. Return: on 3-20-2024: returned product 1 v3 universal ring (blue, new and improved v5 version) broken in half at the pivot point. Overmolding date codes ¿b¿ for february and ¿o¿ for 2023. Dhr and retain evaluation to be...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it is reported that palodent v3 univ 2 ring refil broke during use. No injury.
Additional Manufacturer Narrative: Returned product was 1 flexshaft date code 0223 with coil deformation/weld failure causing the product to not function properly. Capa-2023 opened to address automatrix flexshaft assemblies breaking for product manufactured by sarasota since september 2022 (date code 0922) through present. Complaint is considered substantiated. There is no batch information provided...show all
Description of Event or Problem: In this event it is reported that automatrix shaft broke during use. The outcome of this event is unknown as of this mdr.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though results are not available...show all
Description of Event or Problem: In this event it is reported that palodent v3 ring broke during use. The outcome of this event is unknown as of this mdr. This complaint was received via facebook message - social media complaint.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. this event, therefore, is reportable per 21cfr part 803.the device is available for evaluation, though has not been returned...show all
Description of Event or Problem: In this event it is reported that automate iii broke during use. No injury.
Additional Manufacturer Narrative: Returned product was 1 automate iii tightening device and 1 flexshaft assembly date coded 0623 with coil deformation/weld failure causing the "tip/burr component to break off resulting in the product to not function properly. Capa-2023 opened to address automatrix flexshaft assemblies breaking for product manufactured by sarasota since (b)(6) 2022...show all
Description of Event or Problem: In this event it is reported that v3 ring universal (green) 2 pack broke during use. No injury.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Additional Manufacturer Narrative: (b)(6) 2024: returned product 1 palodent v3 universal ring (green, v5 version) overmodling date codes ¿j¿ for october and ¿n¿ for 2022. This ring observed to have the overmolding tynes on one side broken and also noticed not symmetrical to the other side (images attached) and does not meet specification...show all
Additional Manufacturer Narrative: Investigation: return (b)(6) 2024: product not returned; image in case depicts 2 palodent v3 universal ring (green, v5 version) overmodling date codes not visible with attached image. Both rings observed to have broken tynes causing the rings to no longer be functional. Dhr and retain evaluation to be conducted. (nwv)...show all
Description of Event or Problem: In this event it is reported that v3 ring universal (green) 2 pack broke during use. No injury.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it is reported that v3 ring narrow (yellow) 2 pack broke during use. No injury.
Additional Manufacturer Narrative: 2-23-2024: returned product 1 palodent v3 narrow ring (yellow, v5 version) overmodling date codes ¿b¿ for february and ¿n¿ for 2022 with one side of the overmolded plastic broken off of the metal spring as the customer describes. After further examination of the returned product, more specifically the condition of...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it is reported that v3 ring narrow (yellow) 2 pack broke during use. No injury.
Additional Manufacturer Narrative: (b)(6) 2024: returned product 1 palodent v3 universal ring (green, v5 version) overmodling date codes ¿j¿ for october and ¿o¿ for 2023. This ring observed to have one of tynes on both sides broken as the customer described. There is no batch information provided in this case, therefore no dhr...show all
Additional Manufacturer Narrative: On 2-15-2024: returned product was 1 flexshaft assembly date coded 1222 with coil deformation/weld failure causing the ¿tip¿ to break off resulting in the product to not function properly. Capa opened to address automatrix flexshaft assemblies breaking for product manufactured by sarasota since september 2022 (date code 0922) through present....show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it is reported that automatrix shaft broke during use. Fragment recovered. No injury.
Additional Manufacturer Narrative: Investigation findings: return. 2-15-2024: returned product was 1 unit of item# 62422510 automatrix refill mt received in original packaging identified as batch# 04216480 containing only 13 of the original 72 medium thin matrix bands. The problem ¿several dies broke in the same place " could not be duplicated to the...show all
Description of Event or Problem: On this event it is reported that automatrix broke during use. No injury occurred.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it is reported that palodent v3 forceps broke during use. No injury.
Additional Manufacturer Narrative: Investigation results: 1-31-2024: product returned 1 pair gen 2 forceps batch# a100121 broken at the handle at the customer describes thus substantiating the customers complaint. Note: this is the first complaint for broken forceps for item# (b)(4) batch# a100121. (nwv). 1-31-2024: incoming retains are no longer available for review as...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it is reported that automatrix shaft tip broke during use. No injury occurred.
Description of Event or Problem: In this event it is reported that palodent plus univ 2 ring broke during use. Reportedly, no medical intervention was required, no injury.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Additional Manufacturer Narrative: Investigation results: (b)(6) 2024: returned product 1 v3 ring universal (light blue, new and improved design v5) with 2 of the tynes broken off as described in the detail of this case. Overmolding date codes ¿c¿ for (b)(6) and ¿o¿ for 2023. Dhr nor retain evaluation can be conducted as...show all
Description of Event or Problem: In this event it is reported that automatrix shaft broke during use. Outcome of this event is unknown as of this mdr. Further information requested.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Additional Manufacturer Narrative: Investigation results: returned product was 1 flexshaft date code 0523 with coil deformation/weld failure causing the product to not function properly. Capa opened to address automatrix flexshaft assemblies breaking for product manufactured by sarasota since september 2022 (date code 0922) through present. Complaint is considered substantiated. Dhr nor retains can...show all
Description of Event or Problem: In this event it is reported that palodent v3 univ 2 ring refil broke during use. The outcome of this event is unknown as of this mdr. Further information requested.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Additional Manufacturer Narrative: Investigation: failure mode: broken product. Root cause: not determined. Conclusion code: indeterminable. 11-21-2023: product not returned, however image in case depicts 1 v3 ring universal blue with one of the tynes broken off. Overmolding date code couldn¿t completely be identified based on the image quality attached, however one code could...show all
Additional Manufacturer Narrative: The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review. Because the return was not received and the customer did not provide a lot number, no investigation could be completed.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it is reported that palodent plus univ 2 ring ref broke during use. The outcome of this event is unknown as of this mdr.
Description of Event or Problem: In this event it is reported that automatrix shaft tip broke during use. The outcome of this event is unknown as of this mdr.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Additional Manufacturer Narrative: Investigation: returned product was 1 flexshaft assembly date coded 0922 with coil deformation/weld failure causing the product to not function properly which may be due to manufacturing or customer use (indeterminable). There is no batch information provided in case and therefore dhr review and retain evaluation cannot be conducted. (nwv).
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device was not returned for evaluation. However, the lot number...show all
Description of Event or Problem: In this event it is reported that palodent v3 univ 2 ring refil broke during use. No injury occurred.
Additional Manufacturer Narrative: 10-19-2023: product not returned, however image in case depicts 1 v3 ring universal blue (new and improved design v5) with one of the tynes broken off. Overmolding date codes ¿b¿ for february and ¿o¿ for 2023. Dhr and retain evaluation will be conducted. (nwv) 10-19-2023: final packaging product retains are...show all
Description of Event or Problem: In this event it is reported that a automatrix shaft tip broke during use. Reportedly, no injury occurred.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Additional Manufacturer Narrative: Investigation: product not returned. Image attached shows flexshaft date code not visible with weld failure/coil deformation. Capa opened to address weld failures, coil/spring tears/deformation and ¿broken tip¿ for product manufactured by sarasota. Since december 2020 (date code 1220) through implementation date of august 2022 (0822). Based off the batch information...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Description of Event or Problem: In this event it is reported that a automatrix shaft broke during use. No injury occurred.
Additional Manufacturer Narrative: Investigation result: 9-28-2023: returned product was 1 flexshaft date code 0622 with coil deformation/weld failure causing the product to not function properly. Capa opened to address weld failures for product manufactured by sarasota since december 2020 (date code 1220) through implementation date of august 2022 (0822). The batch information provided...show all
Description of Event or Problem: In this event it is reported that v3 ring universal (green) 2 pack broke during use. No injury.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Additional Manufacturer Narrative: Investigation: return 9-29-2023: returned product 1 v3 ring universal (green, new and improved design v5) with one of the tynes broken off/missing. Overmolding date codes ¿b¿ for february and ¿n¿ for 2022. Dhr and retain evaluation will be conducted. (nwv) retain 9-29-2023: final packaging product retains are not kept as...show all
Description of Event or Problem: It was reported that a patient experienced a dental implant loss.
Additional Manufacturer Narrative: Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803. The device was not evaluated because the issue is a known inherent risk of the device. We will continue to track and monitor the trend.
Additional Manufacturer Narrative: Returned product was 2 automate iii handles and 2 flexshaft assemblies date coded 1022 & 1222 with coil deformation/weld failure causing the product to not function properly which may be due to manufacturing or customer use (indeterminable). There is no batch information provided in case and therefore dhr review and...show all
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Description of Event or Problem: In this event it is reported that automate iii broke during use. Further information pending.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device was not returned for evaluation. However, the lot number...show all
Description of Event or Problem: In this event it is reported that a palodent v3 univ 2 ring refil broke during use. The outcome of this event is unknown as of this mdr.
Additional Manufacturer Narrative: Additional information: adding udi # (b)(4). This is a follow up report to report this information. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review. Product will not be returned, lot number unknown.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device was not returned for evaluation. However, the lot number...show all
Description of Event or Problem: In this event it is reported that a palodent v3 univ 2 ring refil broke during use. No injury occurred.
Additional Manufacturer Narrative: Investigation results: return on 8-24-2023: product not returned; images in case shows a v3 universal ring (v5 version) with one of the overmolding tynes broken off confirming the customers complaint. Overmolding date codes could verified ¿b¿ february and ¿o¿ 2023 with image provided, which does not trace back to the...show all
Description of Event or Problem: In this event it is reported that a automatrix shaft broke during use. The outcome of this event is unknown as of this mdr. Further information requested.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. as such, this event is reportable...show all
Additional Manufacturer Narrative: Additional information: adding udi# (b)(4). Date code 0822 with coil deformation/weld failure resulting in the burr/tip component to break off causing the product to not function properly. Capa-2021-375 opened to address weld failures for product manufactured by sarasota since december 2020 (date code 1220) through implementation date of august 2022...show all
Description of Event or Problem: In this event it is reported that a automatrix shaft broke during use. No injury occurred.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Additional Manufacturer Narrative: Returned product was 1 flexshaft date code 0522 with coil deformation/weld failure resulting in the burr/tip component to break off causing the product to not function properly. Capa opened to address weld failures for product manufactured by sarasota since december 2020 (date code 1220) through implementation date of (b)(6) 2022...show all
Additional Manufacturer Narrative: Additional information: adding udi #(b)(4).. This is a follow up report for this information. Investigation: 8-23-2023: returned product was 1 flexshaft date code 0814 with the burr component broken off causing the product to not function properly. This flex shaft was produced in 08-2014 and exceeds the automate flexshaft useful...show all
Description of Event or Problem: In this event it is reported that automatrix shaft broke during use. No injury.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Additional Manufacturer Narrative: Returned product was 1 flexshaft date code 0322 with coil deformation/weld failure resulting in the burr/tip component to break off causing the product to not function properly. Capa (b)(4) opened to address weld failures for product manufactured by sarasota since december 2020 (date code 1220) through implementation date of august...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it is reported that automatrix extra shaft assy broke during use. Reportedly, the broken tip suctioned by suction line.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though results are not available...show all
Description of Event or Problem: In this event it is reported that automatrix shaft broke during use. No injury occurred.
Additional Manufacturer Narrative: 8-2-2023 return investigation: product returned 1 flexshaft date coded 0913 (not from batch 06498993 as input in case) with a broken tip rendering the product unusable. This flexshaft was produced in 09-2013 and exceeds the automate flexshaft useful life rationale which states that automate flexshaft useful life will be established...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though results are not available...show all
Description of Event or Problem: In this event it is reported that automatrix extra shaft assy broke during use in patient's mouth. Broken parts were retrieved, no injury occurred.
Additional Manufacturer Narrative: On 8-2-2023: returned product; only the tip of the flexshaft assembly which has broken off from the rest of the assembly presumably due to coil deformation/weld failure. The date code of the flexshaft assembly could not be identified. No batch information provided in case therefore no dhr or retain evaluation...show all
Description of Event or Problem: In this event it is reported that palodent v3 starter kit broke during use. No injury occurred.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Additional Manufacturer Narrative: Adding udi # : udi # (b)(4). Returned product was 1 automate iii handle and 1 flexshaft date code 0622 with coil deformation/weld failure causing the product to not function properly. Capa-2021-375 opened to address weld failures for product manufactured by sarasota since december 2020 (date code 1220) through implementation...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Description of Event or Problem: In this event it is reported that a automate tool refill broke during use. No injury occurred.
Description of Event or Problem: Contacted denmat holdings regarding instruction for use for their cerisaw anterior finishing system. There were no instructions for use for cleaning or sterilization provided contacted customer service / regulatory. Was told to autoclave but cannot provide a temperature, exposure time or cycle type. Requested specific info and was told to...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was not returned for evaluation and the lot number was not provided...show all
Description of Event or Problem: In this event it is reported that palodent v3 starter kit (v3 ring) broke during use. No injury occurred.
Additional Manufacturer Narrative: The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Additional Manufacturer Narrative: (b)(6) 2023: returned product was only the tip of the flexshaft assembly which is composed of the burr component and the collet subassembly. The tip of the flexshaft inside the collet subassembly where the coil spring is welded together has evidence of weld failure which resulted in the spring coil...show all
Description of Event or Problem: In this event it is reported that automatrix extra shaft assy broke during use. No injury.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it is reported that automatrix extra shaft assy broke during use. The outcome of this event is unknown as of this mdr.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Additional Manufacturer Narrative: 6-19-2023: returned product was only the tip of the flexshaft assembly which is composed of the burr component and the collet subassembly. The tip of the flexshaft inside the collet subassembly where the coil spring is welded together has evidence of weld failure which resulted in the spring coil breaking...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it is reported that automatrix extra shaft assy broke in patient's mouth during use. No injury occurred.
Additional Manufacturer Narrative: 6-29-2023: product not returned, however image attached depicts an automate iii handle assembly with flexshaft installed (date code could not be verified with image) with coil deformation caused by weld failure rendering the product unusable. Capa-2021-375 opened to address weld failures, coil/spring tears/deformation and ¿broken tip¿ for product manufactured by...show all
Additional Manufacturer Narrative: Investigation type return (b)(6) 2023: returned product 4 universal rings (green ¿ triodent) of which 3 were broken in half and 1 extremely worn out/evidence of long-term usage and was not broken/damaged. Date code for the 1 non-broken ring ¿c¿ for (b)(6) and ¿i.¿ for 2019, i which this ring...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it is reported that v3 ring universal (green) 2 pk broke during use. No injury.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21 cfr part 803. The device is available for evaluation, though results are not...show all
Description of Event or Problem: In this event it is reported that palodent v3 forceps broke during use. No injury occurred.
Additional Manufacturer Narrative: (b)(6) 2023: returned product 1 pair forceps (gen 1) batch a050820 broken at the ¿pin¿ location thus substantiating the customers complaint. Receiving inspection dhr to be evaluated. (nwv) (b)(6) 2023: incoming retains are kept from the initial batch of 68 samples tested back in (b)(6) 2020 and are no longer...show all
Description of Event or Problem: In this event it is reported that a automatrix shaft broke during use. The outcome of this event is unknown as of this mdr.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though results are not available...show all
Additional Manufacturer Narrative: Product not returned, lot number unknown. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review. Complaint will be reopened if suspect product or investigation result arrives per 8000-sop-038.
Description of Event or Problem: In this event it is reported that a palodent v3 univ 2 ring refil broke during use. No injury occurred.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Additional Manufacturer Narrative: 5-10-2023: returned product v3 ring universal (new improved v5 ring) with 3 broken tynes. Overmolding id ¿e¿ may & ¿n¿ 2022. Product does not meet specification, dhr review/retain evaluation to occur. (nwv). 5-10-2023: final product retains are not kept as per normal procedure. Ring over-molding retains from batches 05512213 &...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it is reported that a automate iii broke during use.automatrix broke. The outcome is unknown as of this mdr. Further information requested.
Additional Manufacturer Narrative: Investigation summary: returned product was 1 flexshaft date code 0921 with coil deformation/weld failure causing the product to not function properly. Capa opened to address weld failures for product manufactured by sarasota since december 2020 (date code 1220) through implementation date of august 2022 (0822). Complaint is considered substantiated. (nwv).
Description of Event or Problem: In this event it is reported that a automatrix extra shaft assembly broke during use. No injury occurred.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Additional Manufacturer Narrative: Udi # (b)(4). Returned product was 1 flexshaft date code 0822 with coil deformation/weld failure causing the product to not function properly. Capa opened to address weld failures for product manufactured by sarasota since december 2020 (date code 1220) through implementation date of august 2022 (0822). Complaint is considered substantiated....show all
Additional Manufacturer Narrative: Adding udi # : udi # (b)(4). Returned product was 1 automate iii handle and 1 flexshaft date code 1021 with coil deformation/weld failure causing the product to not function properly. Capa-2021-375 opened to address weld failures for product manufactured by (b)(4) since december 2020 (date code 1220) through implementation...show all
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Description of Event or Problem: In this event it is reported that a automate tool refill broke during use. Reportedly, no injury.
Description of Event or Problem: In this event it is reported that a v3 supercurve broke during use. No injury occurred.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Additional Manufacturer Narrative: Investigation results: 4-7-2023: returned product v3 ring narrow yellow (new improved v5 ring) with broken tyne. Overmolding id ¿d¿ april & ¿n¿ 2022. Product does not meet specification, dhr review/retain evaluation to occur. (nwv) dhr review: 4-7-2023: dhr for item# 403316 lot# 05623250 has been pulled, reviewed, and attached to...show all
Description of Event or Problem: In this event it is reported that automate tool broke during use. Outcome is unknown as of this mdr. Further information is pending.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Additional Manufacturer Narrative: Adding udi # : udi # (b)(4). Returned product was 1 flexshaft date code 0622 with coil deformation/weld failure causing the product to not function properly. Capa opened to address weld failures for product manufactured by sarasota since december 2020 (date code 1220) through implementation date of august 2022 (0822)....show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Description of Event or Problem: In this event it is reported that a v3 super curve kit broke during use. No injury.
Additional Manufacturer Narrative: Dhr review: 4-7-2023: dhr for item# 403316 lot# 05243873 has been pulled, reviewed, and attached to this case. Dhr review did not indicate any production issues while packaging/labeling the v3 surpercurve kit. Work order 05243873 is the packaging work order which utilized 2 different v3 universal over-molding of the springs...show all
Additional Manufacturer Narrative: Investigation results: 1. (b)(6) 2023: product not returned but image of v3 ring with a broken tyne was provided/attached in the case. The overmolding date id code for 1 side reads ¿g¿ for (b)(6) and ¿n¿ for 2022. Dhr and retain evaluation will be conducted. (nwv). 2. (b)(6) 2023: final...show all
Description of Event or Problem: In this event it is reported that a palodent v3 univ 2 ring refil broke during use. No injury occurred.
Additional Manufacturer Narrative: Investigation findings: 1-23-2023: product not returned but image of v3 ring with a broken tyne was provided/attached in the case. The overmolding date id code for 1 side reads ¿g¿ for july and ¿n¿ for 2022. Dhr and retain evaluation will be conducted. (nwv). Final product retains are not kept...show all
Description of Event or Problem: In this event it is reported that a automatrix extra shaft assy broke during use. No injury occurred.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Additional Manufacturer Narrative: Capa-2021-375 has been opened to address weld failures for product manufactured by sarasota since december 2020 (date code 1220). Complaint is considered substantiated.
Additional Manufacturer Narrative: Adding udi # : udi # (b)(4). Returned product was 1 flexshaft date code 0622 with coil deformation/weld failure causing the product to not function properly. Capa opened to address weld failures for product manufactured by sarasota since (b)(6) 2020 (date code 1220) through implementation date of (b)(6) 2022 (0822)....show all
Description of Event or Problem: In this event it is reported that automatrix extra shaft assy broke during use; customer states when the extra shaft assembly was in the patient's mouth and the dentist was winding it tighter it snapped. No injury occurred.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Description of Event or Problem: In this event it is reported that palodent v3 forceps broke during use in patient's mouth. No injury occurred.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Additional Manufacturer Narrative: 1-5-2023: returned product 1 pair of forceps with lot a070121 etched on the handle. The returned forceps broke in half at the ¿pin¿ component of the forceps as the customer describes. The complaint is considered substantiated. (nwv). Dhr: 1-5-2023: incoming/receiving documents for lot# a070121 forceps has been pulled, reviewed, and...show all
Additional Manufacturer Narrative: Product will not be returned, it is not a complaint. Lot number unknown, unable to do a retain investigation.
Additional Manufacturer Narrative: While it is unknown if the device used in this case caused or contributed to the patient¿s symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same...show all
Description of Event or Problem: In this event it is reported that a patient may have experienced an adverse reaction after undergoing a dental procedure that involved the use of palodent v3. It is reported that patient presented with redness of buccal gingiva and has an allergy to nickel. Outcome of this event is unknown...show all
Additional Manufacturer Narrative: Investigation findings: returned product one pair gen 2 forceps batch a081521 broken at the handle. Incoming/receiving documents for lot# a081521 forceps has been pulled, reviewed for this case. All incoming supplier documentation/certifications meet specifications as well as all visual, dimensional, and functional tests as per 0290-ip-ri-instruments. A total of (b)(4)...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Description of Event or Problem: In this event it is reported that a palodent plus forceps broke during use. No injury occurred.
Additional Manufacturer Narrative: A capa was opened to address weld failures, coil/spring tears/deformation and ¿broken tip¿ for product manufactured by sarasota since december 2020 (date code: 1220) through implementation date of august 2022 (0822). Batch: 04759251 utilized flex shaft assembly item: 20780, batch: 04759292 which was produced in oct 2021 (date code: 1021)....show all
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Description of Event or Problem: In this event it is reported that automatrix broke during use. The tightening assembly shaft broke when tightening automatrix band inside patients mouth. Outcome of this event is unknown as of this mdr.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it is reported that a automate tool tip broke during use in patient's mouth. Broken part was retrieved from patient's mouth. No injury occurred.
Additional Manufacturer Narrative: Returned product was 1 automate iii handle and 1 flex shaft date code 1121 with coil deformation/weld failure causing the product to not function properly. (b)(4) opened to address weld failures for product manufactured by sarasota since december 2020 (date code 1220) through implementation date of august 2022 (0822). Complaint...show all
Additional Manufacturer Narrative: Returned product was 1 automate iii handle and 1 flexshaft date coded 0721 (manufactured july 2021) with weld failure causing the tip or burr component to be removed from the flexshaft assembly thus causing the product to not function properly. A capa has been opened to address weld failures for...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event. Therefore; is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Description of Event or Problem: In this event it is reported that automate tool broke during use while in patient's mouth. No injury occurred.
Additional Manufacturer Narrative: Investigation summary: found: fail;broken. Manufacturing error. Conclusion: product failure - manufacturing.
Description of Event or Problem: In this event it is reported that palodent v3 1 ring broke during use. No injury occurred.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21 cfr part 803. The device is available for evaluation, though results are not...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it is reported that palodent v3 ring broke during use. No injury occurred.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event. Therefore; is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Description of Event or Problem: In this event it is reported that automate tool broke during use. No injury occurred.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it is reported that palodent v3 1 ring broke during use. No injury occurred.
Additional Manufacturer Narrative: Returned product was 3 automate iii handles and 5 flexshafts date coded 0721 (1), 1021 (2) & 1121 (2). Flexshafts returned all observed weld failures/coil deformation causing the product to not function properly/tip to break off. A capa was opened to address weld failures for product manufactured by sarasota since...show all
Description of Event or Problem: In this event it is reported that automatrix shaft broke during use. Additional information is forth coming.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Description of Event or Problem: In this event it is reported palodent v3 forceps broke during use. Broken pieces were all retrieved from patient's mouth. No additional treatment necessary. No injury occurred.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Additional Manufacturer Narrative: Product not returned; however, an image of the suspect product has been provided. The image of the product shows a broken tine in the over molding of the universal ring. The product does not meet specification and is considered substantiated. Final product retains are not kept as per normal procedure....show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude...show all
Description of Event or Problem: In this event it is reported that palodent v3 narrow 2 ring refl broke during use. All broken parts were retrieved from patient's mouth. No injury occurred.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Description of Event or Problem: In this event it was reported that a automatrix shaft broke during use; no injury resulted.
Additional Manufacturer Narrative: Capa-2021-375 has been opened to address weld failures for product manufactured by sarasota since (b)(6) 2020 (date code 1220). Complaint is considered substantiated.
Description of Event or Problem: In this event it is reported that automatrix extra shaft assy tip broke during treatment. No injury occurred.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Additional Manufacturer Narrative: Capa-2021-375 has been opened to address weld failures for product manufactured by sarasota since december 2020 (date code 1220). Complaint is considered substantiated.
Description of Event or Problem: In this event it is reported that automatrix shaft broke during use. No injury occurred.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Additional Manufacturer Narrative: Capa-2021-375 has been opened to address weld failures for product manufactured by sarasota since december 2020 (date code 1220). Complaint is considered substantiated.
Description of Event or Problem: In this event it is reported that a automatrix shaft broke during use no injury resulted.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore; it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Description of Event or Problem: In this event it was reported that a automatrix shaft broke during use; no injury resulted.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Additional Manufacturer Narrative: Capa-2021-375 opened to address weld failures for product manufactured by sarasota since december 2020 (date code 1220). Complaint is considered substantiated.
Description of Event or Problem: In this event it has been reported that automatrix shaft broke during treatment. No injury occurred.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it has been reported that palodent v3 1 ring broke in patient mouth during use. Unknown if any injury occurred as of this mdr.
Additional Manufacturer Narrative: Return failed. Unable to investigate further due unknown lot number.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it has been reported that palodent v3 1 ring broke in patient mouth during use. Unknown if any injury occurred as of this mdr. Additional information has been requested.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Description of Event or Problem: Multiple unsuccessful attempts were made to obtain the patient outcome.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it has been reported that palodent v3 1 ring broke in patient mouth during use. Unknown if any injury occurred as of this mdr. Additional information requested.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Description of Event or Problem: Multiple unsuccessful attempts were made to obtain the patient outcome.
Additional Manufacturer Narrative: After an increased trend, a capa has been opened for further investigation.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned...show all
Description of Event or Problem: In this event it has been reported that automatrix shaft broke during use. The broken part is believed to be swallowed by patient. The patient didn't have any respiratory symptoms. Dentist and patient decided between them that should be okay to leave it. Broken part will hopefully pass through. Dentist...show all
Additional Manufacturer Narrative: Returned product was automate iii handle and 1 flexshaft all date coded 1220 (manufactured dec 2020) with weld failure and/or coil deformation causing the product to not function properly. Capa-2021-375 opened to address weld failures for product manufactured by sarasota since december 2020 (date code 1220). Complaint is considered substantiated.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Description of Event or Problem: In this event it has been reported that automate iii broke during use. No injury to patient.
Additional Manufacturer Narrative: A capa has been opened to address weld failures, coil / spring tears / deformation and "broken tip" for product manufactured by sarasota since (b)(6) 2020. Complaint is considered substantiated.
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though results are not available...show all
Description of Event or Problem: In this event it was reported that automate tool broke. This occurred during a simple filling that was being performed when the wrench broke. The coil unraveled during patient use and the tip broke off. The instrument was sterilized in an autoclave then sent back. No one was harmed and...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though results are not available...show all
Description of Event or Problem: In this event it was reported that automate tool broke. This occurred during a simple filling that was being performed when the wrench broke. The coil unraveled during patient use and the tip broke off. The instrument was sterilized in an autoclave then sent back. No one was harmed and...show all
Additional Manufacturer Narrative: The device was broken as indicated in the complaint. Batch # unknown to conduct dhr review.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Description of Event or Problem: In this event it has been reported that automatrix shaft broke in the patient's mouth during clamping without any consequences, no patient injury.
Additional Manufacturer Narrative: After an increase in trending, a capa has been opened and is under investigation.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Description of Event or Problem: It was reported that automatrix shaft tip broke during treatment. Patient was not injured.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Description of Event or Problem: It was reported customer received the automatrix intro kit and when they were using the tightening device customer states, tensioner broke when tightening matrix in patients mouth. Customer advised verbally that the patient was not injured in anyway.
Additional Manufacturer Narrative: The device was evaluated and found to be broken as indicated in the complaint.
Additional Manufacturer Narrative: In this event it was reported that a palodent plus matrix ring broke during use; no injury resulted. While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per...show all
Description of Event or Problem: It was reported that palodent v3 narrow 2 ring broke. The patient was not injured; it was possible to remove all broken parts from the patient's mouth.
Description of Event or Problem: In this event it was reported that a palodent v3 matrix ring broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Additional Manufacturer Narrative: Returned product was 1 pair of forceps lot# a101518 which were indeed broken in half at the "pin" location of the instrument. Note that the spring and the locking bar returned with the product and were loose/disconnected form the instrument. A dhr review was conducted with no discrepancies noted. Retain...show all
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. as such, this event is reportable...show all
Description of Event or Problem: In this event it was reported that a automatrix shaft broke during use; no injury resulted.
Additional Manufacturer Narrative: Returned product confirmed to be a flexshaft with date code 0621. Returned product observed had a "weld" failure, this is caused when the welding stage of the manufacturing processes is not executed correctly and/or the weld did not hold up after use. The welder is to secure the hex sleeve...show all
Additional Manufacturer Narrative: Beyond useful life.
Description of Event or Problem: In this event it was reported that a v3 triodent ring broke during use; no injury resulted.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was broken as indicated in the complaint.
Description of Event or Problem: In this event it was reported that a palodent v3 matrix ring broke during use; no injury resulted.
Additional Manufacturer Narrative: The device was broken as indicated in the complaint.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a palodent v3 matrix ring broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Returned product was one palodent v3 ring universal. The ring returned was broken in...show all
Description of Event or Problem: In this event it was reported that a palodent v3 matrix ring broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Returned product one v3 ring universal broken in half at the pivot point. Over-molding...show all
Description of Event or Problem: In this event it was reported that a palodent v3 matrix ring broke during use; no injury resulted.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation. A dhr review was conducted with no discrepancies noted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a palodent v3 matrix ring broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. A dhr review was conducted with no discrepancies noted.
Description of Event or Problem: In this event it was reported that a palodent v3 matrix ring broke during use; no injury resulted.
Additional Manufacturer Narrative: The device was evaluated and was broken as indicated in the complaint.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was broken as indicated in the complaint.
Description of Event or Problem: In this event it was reported that a palodent v3 matrix ring broke during use; no injury resulted.
Additional Manufacturer Narrative: Returned product was a single sterilized bag (without original packaging) and contained 1 v3 ring universal (green) and confirmed to be broken in half at the pivot point.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a palodent v3 universal matrix ring broke during use; no injury resulted.
Additional Manufacturer Narrative: The device was broken as indicated in the complaint.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a palodent v3 matrix ring broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was broken as indicated in the complaint.
Description of Event or Problem: It was reported that a palodent sectional matrix ring broke during use. The event outcome is unknown as of this mdr evaluation.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent v3 forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Based upon new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.
Additional Manufacturer Narrative: Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Description of Event or Problem: It was reported that there was an issue with fd258r -micro ndlhldr diam.coated180mm str. According to the complaint description, locked during a coronal suture. No consequence/ no delay. There was no described patient harm. Additional information was not provided nor available / was not available. The adverse event / malfunction...show all
Additional Manufacturer Narrative: The device was broken as indicated in the complaint.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a palodent v3 matrix ring broke during use; no injury resulted.
Additional Manufacturer Narrative: The device was broken as indicated in the complaint.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a palodent v3 matrix ring broke during use; no injury resulted.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: It was reported that a palodent v3 sectional matrix ring broke during use. The event outcome is unknown as of this mdr evaluation.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: A capa is currently open to change suppliers for this device.
Additional Manufacturer Narrative: While there is no indication that serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent v3 forceps broke at the tip. The event outcome is unknown as of this mdr evaluation.
Additional Manufacturer Narrative: Evaluation confirmed the device is broken. A capa is currently open to change suppliers for this device.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Additional Manufacturer Narrative: Since this event resulted in permanent damage to a body structure or permanent impairment of a body function that would require intervention, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur. As such, this event meets the definition...show all
Description of Event or Problem: It was reported that a palodent sectional matrix ring broke during use and chipped a patient's tooth. The event outcome is unknown as of this mdr evaluation.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. A capa is currently open to change suppliers for this device. Note: the covid-19...show all
Description of Event or Problem: In this event it was reported that a pair of palodent v3 forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Evaluation found the device was broken as indicated in the complaint.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Evaluation found the device to be broken as indicated in the complaint.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: Due to previous incident this mdr is considered reportable. In this event it was reported that a pair of palodent v3 forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Description of Event or Problem: It was reported that there was an issue with ergoplant oral silicone wedge . According to the complaint description there was a tear in hole. The complaint product is a new item. The tear was noticed during inspection when the customer received the product. No sample available. There was no...show all
Additional Manufacturer Narrative: Investigation results: we did not receive the product for investigation, but two pictures were provided. The product does not require batch management; a review of the device quality and manufacturing history records is not possible. The failure is most probably supplier related. A product safety case (psc) has been opened...show all
Additional Manufacturer Narrative: Investigation results: there are discolorations and residues remained at the transition between metal part and silicone. The components were examined visually and microscopically. Under microscopic enlargement it can be seen that the metal part is covered with a thin transparent silicon layer. This layer shows several damages. Several residues/contaminations have...show all
Description of Event or Problem: It was reported that there was an issue with a oral silicone wedge . According to the customer it was reported that the product cannot be cleaned properly. During a routine check the customer found residues between the metal insert and the silicone (protein test was positive). There was no...show all
Additional Manufacturer Narrative: Investigation results: there are discolorations and residues remained at the transition between metal part and silicone. Visual investigation: under microscopic enlargement it can be seen that the metal part is covered with a thin transparent silicon layer. This layer shows several damages (tears). Several residues/contaminations have been deposited in this...show all
Additional Manufacturer Narrative: Additional case created. see b5.
Description of Event or Problem: Additional product with the notification number (b)(4) was created. Awareness date is 04.28.2020. Associated medwatch report: 9610612-2020-00175 ((b)(4) dx113); 9610612-2020-00176 ((b)(4) dx115).
Additional Manufacturer Narrative: After a closer examination of the article and the risk of the article, it was found that the article in this size and design does not have a screw in the appropriate and claimed place. Therefore, the error pattern cannot occur with this article. Due to clarification, the report was...show all
Additional Manufacturer Narrative: Additional case created. See b5.
Description of Event or Problem: Additional product with the notification number 400470331 was created. Awareness date is 04.28.2020. Associated medwatch report. 9610612-2020-00175 (400472614 dx113). 9610612-2020-00176 (400472615 dx115).
Additional Manufacturer Narrative: Investigation results: the components were examined visually. The products with the reference code dx113 are made completely out of silicone. They do not have a drilling made of metal, and therefore they do not have a gap where the residues remain. The product does not require batch management; a review...show all
Description of Event or Problem: It was reported that there was an issue with a oral silicone wedge. According to the customer it was reported that the product cannot be cleaned properly. During a routine check the customer found residues between the metal insert and the silicone (protein test was positive). There was no patient...show all
Additional Manufacturer Narrative: Updated investigation: psc added. Investigation results: there are discolorations and residues remained at the transition between metal part and silicone. Visual investigation: under microscopic enlargement it can be seen that the metal part is covered with a thin transparent silicon layer. This layer shows several damages (tears). Several residues/contaminations have...show all
Additional Manufacturer Narrative: General information: we received a complaint about oral silicone wedges from the (b)(6) university, germany. This case is related to case (b)(4)/ (b)(4)/ (b)(4). The 2 devices dx114 are dealt with in this 8d report. Consequences for the patient: according to the available information, there were no negative consequences for...show all
Additional Manufacturer Narrative: Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Description of Event or Problem: It was reported that there was an issue with ergoplant oral silicone wedge. According to the complaint description it was reported that the product cannot be cleaned properly. According to the customer, the product cannot be cleaned properly. During a routine check, the customer has found residues between the metal...show all
Additional Manufacturer Narrative: A capa is currently open to change suppliers for this device. Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent v3 forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: A capa is currently open to change suppliers for this device. Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.
Additional Manufacturer Narrative: A capa is currently open to change suppliers for this device. Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: The device was broken as indicated in the complaint.
Additional Manufacturer Narrative: A capa is currently open to change suppliers for this device.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: A capa is currently open to change suppliers for this device.
Description of Event or Problem: No further event information available at the time of this report.
Additional Manufacturer Narrative: The reported unknown biomet driver was not identified, and was not returned for inspection. However, one 3i t3® with dcd® non-platform switched tapered implant 5 x 10mm (bnst510) was returned for investigation. Functional testing was performed for the implant and it was determined the implant was noted to assemble and...show all
Additional Manufacturer Narrative: Zimmer biomet complaint (b)(4). Device was not returned.
Description of Event or Problem: It was reported that during implant placement while transferring the implant into patient mouth, an unknown biomet driver disengaged the implant prior placement and implant dropped on the floor. Procedure could not be completed.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Evaluation confirmed the tip is broken as indicated in the complaint.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation. The dhr could not be located to complete a review. No retains are kept for this device.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was not returned for evaluation. However, the lot number was provided and...show all
Description of Event or Problem: In this event it was reported that a pair of palodent v3 forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Evaluation confirmed the device is broken as indicated in the complaint. Root causes not identified. Correction: a correction was made to the patient code in h6.
Additional Manufacturer Narrative: Evaluation confirmed the device is broken as indicated in the complaint. Root causes not identified. Correction: a correction was made to the patient code.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent v3 forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: Exemption number: e2014018. Investigation: failure description: the needle holder is in a heavily used condition, several stains and points of corrosion can be found all over the surface. Also the working end is coated in black. A pictorial documentation was visually and microscopically carried out. Several signs of wear and...show all
Description of Event or Problem: It was reported that intraoperatively the diamant coating comes off the instrument. It was reported that the needle holders (5) are losing the diamant coatings due to abrasion in the area of the branches (area where suture and needle is catches); this was noticed at the end of 2018. Five...show all
Additional Manufacturer Narrative: Exemption number: e2014018. Investigation: failure description: the needle holder is in a heavily used condition, several stains and points of corrosion can be found all over the surface. Also the working end is coated in black. A pictorial documentation was visually and microscopically carried out. Several signs of wear and...show all
Description of Event or Problem: It was reported that intraoperatively the diamant coating comes off the instrument. It was reported that the needle holders (5) are losing the diamant coatings due to abrasion in the area of the branches (area where suture and needle is catches); this was noticed at the end of 2018. Five...show all
Additional Manufacturer Narrative: Exemption number: e2014018. Investigation: failure description: the needle holder is in a heavily used condition, several stains and points of corrosion can be found all over the surface. Also the working end is coated in black. A pictorial documentation was visually and microscopically carried out. Several signs of wear and...show all
Description of Event or Problem: It was reported that intraoperatively the diamant coating comes off the instrument. It was reported that the needle holders (5) are losing the diamant coatings due to abrasion in the area of the branches (area where suture and needle is catches); this was noticed at the end of 2018. Five...show all
Additional Manufacturer Narrative: Exemption number: e2014018. Investigation: failure description: the needle holder is in a heavily used condition, several stains and points of corrosion can be found all over the surface. Also the working end is coated in black. A pictorial documentation was visually and microscopically carried out. Several signs of wear and...show all
Description of Event or Problem: It was reported that intraoperatively the diamant coating comes off the instrument. It was reported that the needle holders (5) are losing the diamant coatings due to abrasion in the area of the branches (area where suture and needle is catches); this was noticed at the end of 2018. Five...show all
Additional Manufacturer Narrative: Exemption number: e2014018. Investigation: failure description: the needle holder is in a heavily used condition, several stains and points of corrosion can be found all over the surface. Also the working end is coated in black. A pictorial documentation was visually and microscopically carried out. Several signs of wear and...show all
Description of Event or Problem: It was reported that intraoperatively the diamant coating comes off the instrument. It was reported that the needle holders (5) are losing the diamant coatings due to abrasion in the area of the branches (area where suture and needle is catches); this was noticed at the end of 2018. Five...show all
Additional Manufacturer Narrative: Evaluation confirmed the device is broken as indicated in the complaint. Root causes not identified. Will continue to track and trend.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent v3 forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Root cause not established. We will continue to track and trend.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation. The dhr could not be located for this lot.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Evaluation found the device was broken as indicated in the complaint.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent v3 forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: The device was broken as indicated in the complaint.
Additional Manufacturer Narrative: The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: The vendor found that excessive pressure caused the deformity in the forceps. Multiple unsuccessful attempts were made to obtain the patient outcome.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps were bent at the tip. The event outcome is unknown as of this mdr evaluation.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Evaluation confirmed the device is broken.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation. A dhr review was conducted with no discrepancies noted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps were bent at the tip; no injury resulted.
Additional Manufacturer Narrative: While there is no indication that a serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent v3 forceps broke at the tip. The event outcome is unknown as of this mdr evaluation.
Additional Manufacturer Narrative: Electricity was shut down / interrupted during the annealing process, due to very heavy electric load shading during that time. A scar has been issued to the original manufacturer to correct this issue.
Additional Manufacturer Narrative: Evaluation confirmed the tip is broken. A capa was initiated for tip breakage for this batch and investigation showed that the failures for this lot may be related to the supplier's manufacturing process. A scar has been issued to the supplier to further investigate the issue. Multiple unsuccessful attempts were...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent v3 forceps broke at the tip. The event outcome is unknown as of this mdr evaluation.
Additional Manufacturer Narrative: Evaluation found a broken tip. A dhr review was conducted with no discrepancies noted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Description of Event or Problem: A metal piece from a root tip pick broke off inside of the patient's mouth during a dental procedure.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation. A dhr review was conducted with no discrepancies noted.
Additional Manufacturer Narrative: Evaluation found the device was beyond useful life.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. This report is for the first device. Evaluation of the forceps confirmed they are...show all
Description of Event or Problem: In this event it was reported that two pairs of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. This report is for the second device. Evaluation of the forceps confirmed they are...show all
Description of Event or Problem: In this event it was reported that two pairs of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation. A dhr review was conducted with no discrepancies noted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was not returned for evaluation. However, the lot number was provided and...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Description of Event or Problem: An alleged complaint was reported that a file broke in the patient's canal resulting in the doctor extracting the patient's tooth.
Additional Manufacturer Narrative: This update is to state that the device in the alleged incident was evaluated by the manufacturer through a visual and functional test. The tests yielded the device meeting all specifications. In addition, this update is also to update the lot serial number. The serial number on this follow up...show all
Description of Event or Problem: An alleged complaint was reported that a file broke in the patient's canal resulting in the doctor extracting the patient's tooth. Patient information: age, sex, weight, ethnicity, and race were not provided from the complainant.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: The actual device was not investigated because this failure is a known issue. A scar was initiated for tip breakage for this batch and investigation showed that the annealing process was interrupted when the electricity was shut down.
Additional Manufacturer Narrative: Additional information was received indicating that the information that was originally reported was incorrect. There was no breakage of the forceps. Therefore, this event is not considered reportable per 21cfr part 803.
Additional Manufacturer Narrative: While there is no indication that serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip. The event outcome is unknown as of this mdr evaluation.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip after cleaning; no patient was involved.
Additional Manufacturer Narrative: Forceps have a broken (right) tip. They are quite contaminated with dark marks especially around the pivot. No further evidence of misuse (no bends, no scratches). Although out of warranty the tips shouldn't break with normal use.
Additional Manufacturer Narrative: Therefore, because medical intervention was required to preclude a serious injury, this event is reportable per 21cfr part 803. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Description of Event or Problem: It was reported that a v3 triodent universal ring was swallowed by a patient during a dental procedure. The clinician did not use a rubber dam as recommended per the ifu. The patient was sent to a gi specialist who retrieved the ring with an endoscope.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was not returned for evaluation. However, the lot number was provided and...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Electricity was shut down / interrupted during the annealing process, due to very heavy electric load shading during that time. A scar has been issued to the original manufacturer to correct this issue.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Electricity was shut down / interrupted during the annealing process, due to very heavy electric load shading during that time. A scar has been issued to the original manufacturer to correct this issue.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was not returned for evaluation. However, a dhr review was conducted with...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation. A dhr review was conducted with no discrepancies noted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip while picking up a matrix ring (outside of a patient's mouth); no injury resulted.
Additional Manufacturer Narrative: Evaluation shows the left tip has broken off. The right tip is still intact. A scar has been issued to the supplier to further investigate the issue.
Additional Manufacturer Narrative: The right tip has broken off. Other tip still looks ok. No other signs of bending or cracking across the forceps. A scar has been issued to the original manufacturer to correct this issue.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction with a similar device resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this report. Evaluation results will...show all
Description of Event or Problem: In this event it was reported that a pair of palodent v3 forceps broke at the tip. The event outcome is unknown as of this mdr evaluation.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent v3 forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Evaluation found that the tip was not broken, but instead the pivot is broken.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke. The event outcome is unknown as of this mdr evaluation.
Additional Manufacturer Narrative: Electricity was shut down / interrupted during the annealing process, due to very heavy electric load shading during that time. A scar has been issued to the original manufacturer to correct this issue.
Additional Manufacturer Narrative: Right tip has broken off. Fracture surface shows signs of corrosion well across the surface which indicates there was likely a crack in the bent area for some time before the breakage. The left tip is still intact but it also has a crack in the bend which would also...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Description of Event or Problem: Received notice from a dentist that after injecting the patient, the needle broke in patients mouth. The patient was then sent to a oral surgeon to have it removed.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Evaluation found a micro fracture resulted due to press stroke due to very cold weather. Workshop room temperature has been improved during cold weather and further micro inspections are carried out.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Forceps have broken front arm halfway between tip and pivot. Cross section of broken arm suggests weakness in metal. A scar has been issued to the original manufacturer to correct this issue.
Additional Manufacturer Narrative: Tip from left arm has broken off. No further damage seen. Cleaning method used ultrasonic. This may have caused the breakage.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Power failure during one of the processes resulted in incomplete processes as a result of some specific lot numbers were affected. A scar has been issued to the original manufacturer to correct this issue.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Evaluation found the device is beyond useful life.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps was bent at the tip; no injury resulted.
Additional Manufacturer Narrative: Evaluation found that the tip was not bent as indicated in the complaint. Instead, the pivot is bent, causing the whole left arm to tilt down. As a result the tip is now more vertical while it should point outwards and therefore lost its ability to hold a ring. This...show all
Additional Manufacturer Narrative: Therefore, because there is a possibility that the device may have caused or contributed to a serious injury, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted...show all
Description of Event or Problem: It was reported that after use of several palodent plus universal matrix rings (exact number unknown) during a filling procedure, it was noticed that several teeth had "hairline fractures" at the margin. The fractures were unnoticed until the procedure was finished. As the defects were noticed after the procedure it...show all
Additional Manufacturer Narrative: Rings look a bit worn with some composite buildup. One of the rings is a bit stretched, tines are further open than new ring. Otherwise nothing abnormal with both rings.
Additional Manufacturer Narrative: The device was lost during transit and cannot be evaluated.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip. The event outcome is unknown as of this mdr evaluation. Additional information is being requested.
Additional Manufacturer Narrative: Additional information was received indicating that there was no injury to the patient.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Power failure during one of the processes resulted in incomplete processes as a result of some specific lot numbers were affected which we are now working with the supplier to resolve the issue.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Electricity was shut down / interrupted during the annealing process, due to very heavy electric load shading during that time. A scar has been issued to the original manufacturer to correct this issue.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Product received with right arm tip detached. Product inspected using 25x magnification. Broken arm...show all
Description of Event or Problem: In this event it was reported that a pair of triodent forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: During the dental procedure, the instrument was used to check for mobility of tooth. This instrument's intended use is for reflecting and retracting the mucoperiosteum after incisions of the gingival tissue. No manufacturing defects were found during evaluation. There is a low level of return rates on this instrument. Hu-friedy...show all
Description of Event or Problem: It was reported to us that the adverse event occurred while the patient was having extensive dental work. The dentist was using the instrument interproximally between tooth 3 and 4 to check for mobility when the device fractured. The dentist called the ent into the operating room, where an x-ray...show all
Additional Manufacturer Narrative: Power failure during one of the processes resulted in incomplete processes as a result of some specific lot numbers were affected, which we are now working with the supplier to resolve the issue. Furnace operators haves been instructed to use in house electric generator during this process.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: .
Description of Event or Problem: During a dental procedure, part of the dental instrument broke off into the patient. After the scheduled procedure, the patient had to be taken to the operating room to remove the foreign body. Manufacturer response for woodson periosteal double ended dental instrument, (brand not provided) (per site reporter): the manufacturer...show all
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Description of Event or Problem: On 01/11/2016 it was reported that a pair of palodent plus forceps was damaged with very little use. When the product was received on 03/16/2016, it was noticed that the tip was broken on the forceps. No injury resulted.
Additional Manufacturer Narrative: Returned product inspected using 20x magnification. Evidence of stress corrosion cracks present at point of break and cracks visible at base of tip on detached arm.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event, it was reported that a pair of triodent forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke at the tip and cut a patient's lip; no intervention was required.
Additional Manufacturer Narrative: End part received excess grinding & high voltage spot welding. Instruments grinding has been improved, ensuring the spot welding machine are working with appropriate voltage with precise settings.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Left arm tip has broken off. Evidence of stress corrosion cracking. A capa was initiated for tip breakage for this batch and investigation showed that the failures for this lot may be related to the supplier's manufacturing process. A scar has been issued to the supplier to further investigate the...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Returned product had a missing left arm tip. Product examined with 15 x magnification....show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. This report is for the first device. The device is available for evaluation, though...show all
Description of Event or Problem: In this event it was reported that a two pairs of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Product lost in post whilst in transit to the supplier for further investigation, so no investigation can occur.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps was bent at the tip. The event outcome is unknown as of this mdr evaluation. Additional information has been requested, but is not yet available.
Additional Manufacturer Narrative: The device evaluation found that the left arm is bent at the point of pivot. Also, the tip angles were inspected and the angles are over size. Product does not meet specification.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. This report is for the second device. The device is available for evaluation, though...show all
Description of Event or Problem: In this event it was reported that a two pairs of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Product lost in post whilst in transit to the supplier for further investigation, so no investigation can occur.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Power failure during one of the processes resulted in incomplete processes as a result of some specific lot numbers were affected, which we are now working with the supplier to resolve the issue.
Additional Manufacturer Narrative: Forceps visually inspected left arm tip had a reduced angle. Product out of specification.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Electricity was shut down / interrupted during the annealing process, due to very heavy...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was not returned for evaluation. A picture of the broken device was...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Product examined under 20 x magnification - left tip missing. Evidence would point to manufacturing forming and finishing as a root cause. Scar issued to original manufacturer to correct the issue.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip. The event outcome is unknown as of this mdr evaluation. Additional information is being requested.
Additional Manufacturer Narrative: Electricity was shut down / interrupted during the annealing process, due to very heavy electric load shading during that time. A scar has been issued to the original manufacturer to correct this issue.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. This report is for the second device. The device is available for evaluation, though...show all
Description of Event or Problem: In this event it was reported that two pairs of palodent plus forceps broke at the tip after cleaning; no patient was involved and no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. This report is for the first device. The device is available for evaluation, though...show all
Description of Event or Problem: In this event it was reported that two pairs of palodent plus forceps broke at the tip after cleaning; no patient was involved and no injury resulted.
Additional Manufacturer Narrative: Electricity was shut down / interrupted during the annealing process, due to very heavy electric load shading during that time. A scar has been issued to the original manufacturer to correct this issue.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The actual device was not investigated because this failure is a known issue. A...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip. The event outcome is unknown as of this mdr evaluation. Additional information is being requested.
Additional Manufacturer Narrative: Electricity was shut down / interrupted during the annealing process, due to very heavy electric load shading during that time. A scar has been issued to the original manufacturer to correct this issue.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of triodent forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Evaluation of the forceps using 30x magnification found scoring on the underside of the remaining tip. This type of defect is typical of poor manufacturing process in finishing . Forceps hardness results average = 48, which is within specification.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Electricity was shut down / interrupted during the annealing process, due to very heavy electric load shading during that time. A scar has been issued to the original manufacturer to correct this issue.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Electricity was shut down / interrupted during the annealing process, due to very heavy electric load shading during that time. A scar has been issued to the original manufacturer to correct this issue.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Electricity was shut down / interrupted during the annealing process, due to very heavy electric load shading during that time. A scar has been issued to the original manufacturer to correct this issue.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Evaluation found the device to be past useful life.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: The actual device was not investigated because this failure is a known issue. A capa was initiated for tip breakage for this batch and investigation showed that the failures for this lot may be related to the supplier's manufacturing process. A scar has been issued to the supplier to further...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21cfr part 803. The device is available for evaluation, though has not been returned as of this report....show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip. The event outcome is unknown as of this mdr evaluation. Additional information is being requested.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was not returned for evaluation. However, the lot number was provided and...show all
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the patient outcome. The device was not returned for evaluation.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report rec'd where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are not available as of this...show all
Additional Manufacturer Narrative: Electricity was shut down / interrupted during the annealing process, due to very heavy electric load shading during that time. A scar has been issued to the original manufacturer to correct this issue.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Electricity was shut down / interrupted during the annealing process, due to very heavy electric load shading during that time. A scar has been issued to the original manufacturer to correct this issue.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21cfr part 803. The device is available for eval, though has not been returned as of this report....show all
Additional Manufacturer Narrative: Electricity was shut down / interrupted during the annealing process, due to very heavy electric load shading during that time. A scar has been issued to the original manufacturer to correct this issue.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21cfr part 803. The device is available for evaluation, though results are not available as of this report....show all
Additional Manufacturer Narrative: Electricity was shut down / interrupted during the annealing process, due to very heavy electric load shading during that time. A scar has been issued to the original manufacturer to correct this issue.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for evaluation. The lot number reported does not exist.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for eval. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. The device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Additional Manufacturer Narrative: Electricity was shut down / interrupted during the annealing process, due to very heavy electric load shading during that time. A scar has been issued to the original manufacturer to correct this issue.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: There has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they...show all
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke at the tip while stretching a matrix ring outside of a pts mouth; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. The device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip outside of a pts' mouth; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted din a serious injury. Therefore, this event meets the criteria for re portability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of...show all
Additional Manufacturer Narrative: Multiple unsuccessful attempts were made to obtain the device for eval. A dhr review was conducted with no discrepancies noted.
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that three pairs of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report rec'd where this malfunction resulted in a serious injury. This report is for the second device. The device is available for eval, though results are not available as of this report. Eval results will be submitted...show all
Description of Event or Problem: In this event it was reported that three pairs of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report rec'd where this malfunction resulted in a serious injury. This report is for the first device. The device is available for eval, though results are not available as of this report. Eval results will be submitted...show all
Description of Event or Problem: In this event it was reported that three pairs of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report rec'd where this malfunction resulted in a serious injury. This report is for the third device. The device is available for eval, though results are not available as of this report. Eval results will be submitted...show all
Description of Event or Problem: In this event, it was reported that a pair of triodent forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. This report is for the first device. The device is available for eval, though...show all
Description of Event or Problem: In this event it was reported that two pairs of palodent plus forceps broke at the tip while in the sterilizer; no patients were involved.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report rec'd where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are not available as of this...show all
Description of Event or Problem: In this event, it was reported that two pairs of palodent plus forceps broke at the tip while in the sterilizer; no pts were involved.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. This report is for the second device. The device is available for evaluation, though...show all
Description of Event or Problem: In this event it was reported that two pairs of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report rec'd where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. This report is for the second device.
Description of Event or Problem: In this event it was reported that two pairs of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report rec'd where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. This report is for the first device. The device was not returned for eval...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report rec'd where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though has not been returned as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are not available as of this...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; there is no indication that injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a pervious report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The returned device was evaluated and found to be within spec.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip: no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Fracture surface shows signs of corrosion well across the...show all
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received with a similar device where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been...show all
Description of Event or Problem: In this event, it was reported that a pair of triodent forceps broke at the tip; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received within the past 2 years where this malfunction resulted in a serious injury; therefore, this event meets the criteria for reportability per 21 cft part 803. The device is available for eval, though results are...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received with a similar device where this malfunction resulted in a serious injury; therefore, this event meets the criteria for reportability per 21 cft part 803. The device is available for eval, though has not been...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received with a similar device where this malfunction resulted in a serious injury; therefore, this event meets the criteria for reportability per 21 cft part 803. The device is available for eval, though has not been...show all
Description of Event or Problem: In this event it was reported that a pair of triodent forceps broke at the tip; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Electricity was shut down/interrupted during the annealing process, due...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip and cut a pt; no intervention was required.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Description of Event or Problem: On (b)(6) 2014, a dentist had reported that a palodent plus clamp broke. However, when the product was received on (b)(6) 2014, it was found to be a pair of palodent plus forceps that had broken at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where a broken tip on the forceps resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Fracture surface shows large grain...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr 803. Fracture surface shows signs of corrosion. The corrosion covers approximately...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability 21 cfr part 803. The device is available for evaluation, though results are not...show all
Description of Event or Problem: On (b)(6) 2014 it was reported that a pair of palodent plus forceps had broken at the connection point and not at the tip. However, when the product was received on (b)(6) 2014 it was found that the forceps were broken at the tip. No injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this a broken tip resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr 803. Inspection under microscope shows large grain size and...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the joint. However, when received it was the tip that was broken. There was no report of injury.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. There is evidence the tip had been cracked for...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps cracked at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of triodent forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received with a similar device where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous repost received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps would drop the rings without releasing them; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where a ring that was unintentionally released from a pair of forceps resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803....show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Electricity was shut down / interrupted during the annealing...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Electricity was shut down / interrupted during the annealing...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this events meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke.
Additional Manufacturer Narrative: The event outcome is unknown as of this mdr evaluation. However, there is no indication that injury resulted. While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets criteria for reportability per 21 cfr part 803. The device is available for eval, though results are not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets criteria for reportability per 21 cfr part 803. The device is available for eval, though results are not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps bent at the tip during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though has not...show all
Description of Event or Problem: In this event is was reported that a pair of palodent plus forceps broke; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Electricity was shut down / interrupted during the annealing...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: The dental implant hex rounded out due to the implant driver. implant was explanted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event, it was reported that the tip on a pair triodent forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction with a similar device resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction with a similar device resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for...show all
Description of Event or Problem: In this event it was reported that a pair of triodent forceps broke; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use and hit a pt's lip, causing pain; however no serious injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; the separated piece was retrieved and no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received for a similar device in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received for a similar device in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for...show all
Description of Event or Problem: In this event it was reported that a pair of palodent bi-tine ring placement forceps broke; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets ths criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent bi-tine ring placement forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received for a similar device in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 crf part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 crf part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps tips were not straight and rings were falling off the tips; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Electricity was shut down / interrupted during the annealing...show all
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; the pts' cheek was scratched; no intervention was required.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Additional Manufacturer Narrative: In this event it was reported that a pair of palodent plus forceps broke during use; a pts' cheek was scratched; no intervention was required. The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during ue; a pts' cheek was scratched; no intervention was required.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report rec'd in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Electricity was shut down / interrupted during the annealing...show all
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report rec'd in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Electricity was shut down / interrupted during the annealing...show all
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report rec'd in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was evaluated and found to be misaligned...show all
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report rec'd in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Electricity was shut down / interrupted during the annealing...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Electricity was shut down/ interrupted during the annealing process,...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report rec'd in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Electricity was shut down / interrupted during the annealing...show all
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report rec'd in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Electricity was shut down / interrupted during the annealing...show all
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report rec'd in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Electricity was shut down / interrupted during the annealing...show all
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Electricity was shut down/ interrupted during the annealing process,...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was lost in post and therefore not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps do not stay in locked position when the ring is engaged; no injury resulted. The device was evaluated and found to have micro fractures.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction (micro fractures) resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Electricity was shut down/ interrupted during the...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Electricity was shut down/ interrupted during the annealing process,...show all
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps were "defective"; no injury resulted.
Additional Manufacturer Narrative: The device was evaluated and found to have micro fractures. While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction (micro fractures) resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21...show all
Description of Event or Problem: In this event is was reported that a pair of palodent plus forceps could not be fixed; no injury resulted.
Additional Manufacturer Narrative: The device was evaluated and found to be misaligned possibly due to the customer's technique. Additional information from the customer to confirm this is unavailable. During an internal review it was found that this event was originally misclassified. It has been appropriately reclassified and determined to meet the criteria for...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; there is no indication that injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; there is no indication that injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pail of palodent plus forceps broke during use; there is no indication that injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report rec'd in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of a palodent plus forceps broke during use; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; there is no indication that injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event, it was reported that the spring on a pair of palodent plus forceps broke during use; pieces of the spring were retrieved from the pt's throat.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Additional Manufacturer Narrative: Patient information regarding gender, age, and weight were not provided. The doctor removed the core with a drill, repeated the procedure, and completed the restoration. To date, the patient is doing fine. The product was not returned and no lot number was provided; therefore, no evaluation can be completed.
Description of Event or Problem: A doctor alleged that the build-it core forms had created voids in the core build-ups of five (5) patients. It was reported that the voids were found after filling the build-it core forms with material and light curing it. This is the second of five (5) reports.
Additional Manufacturer Narrative: Patient information regarding gender, age, and weight were not provided. The doctor removed the core with a drill, repeated the procedure, and completed the restoration. To date, the patient is doing fine. The product was not returned and no lot number was provided; therefore, no evaluation can be completed.
Description of Event or Problem: A doctor alleged that the build-it core forms had created voids in the core build-ups of five (5) patients. It was reported that the voids were found after filling the build-it core forms with material and light curing it. This is the first of five (5) reports.
Description of Event or Problem: A doctor alleged that the build-it core forms had created voids in the core build-ups of five (5) patients. It was reported that the voids were found after filling the build-it core forms with material and light curing it. This is the third of five (5) reports.
Additional Manufacturer Narrative: Patient information regarding gender, age, and weight were not provided. The doctor removed the core with a drill, repeated the procedure, and completed the restoration. To date, the patient is doing fine. The product was not returned and no lot number was provided; therefore, no evaluation can be completed.
Description of Event or Problem: A doctor alleged that the build-it core forms had created voids in the core build-ups of five (5) patients. It was reported that the voids were found after filling the build-it core forms with material and light curing it. This is the fourth of five (5) reports.
Additional Manufacturer Narrative: Patient information regarding gender, age, and weight were not provided. The doctor removed the core with a drill, repeated the procedure, and completed the restoration. To date, the patient is doing fine. The product was not returned and no lot number was provided; therefore, no evaluation can be completed.
Description of Event or Problem: A doctor alleged that the build-it core forms had created voids in the core build-ups of five (5) patients. It was reported that the voids were found after filling the build-it core forms with material and light curing it. This is the fifth of five (5) reports.
Additional Manufacturer Narrative: Patient information regarding gender, age, and weight were not provided. The doctor removed the core with a drill, repeated the procedure, and completed the restoration. To date, the patient is doing fine. The product was not returned and no lot number was provided; therefore, no evaluation can be completed.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use and the tip cut a pt's lip; no medical intervention was required.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though has not...show all
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted, however, the broken piece was not located by the doctor.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr 803. The device is available for evaluation, though results are not...show all
Additional Manufacturer Narrative: While no serious injury in this event, there have been previous report rec'd in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was not returned for evaluation and the lot number...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets this criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not...show all
Description of Event or Problem: In this event, it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though has not...show all
Description of Event or Problem: This event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Description of Event or Problem: In this event it was reported that a pair of palodent plus forceps broke during use; no injury resulted.
Description of Event or Problem: In this event it was reported that a pair of palodent forceps broke during use and chipped a pt's tooth; the dentist repaired the pt's tooth.
Additional Manufacturer Narrative: Because eval of the unit involved is not complete as of this report and since this issue could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the device malfunctioned and that the malfunction would likely...show all
Description of Event or Problem: In this event it was reported that two pairs of palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been previous report rec'd in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was not returned for evaluation and the lot...show all
Description of Event or Problem: In this event it was reported that a palodent plus forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though results are...show all
Additional Manufacturer Narrative: While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same...show all
Description of Event or Problem: In this event, it was reported that a patient may have experienced an adverse reaction after undergoing a dental procedure that involved the use of the automatrix retaining band as well as other materials; no medical intervention was necessary. The patient exhibited symptoms including a swollen lip. The patient returned...show all
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a palodent plus placement forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a palodent plus placement forceps broke during use; no injury resulted.
Additional Manufacturer Narrative: While no serious injury resulted in this event, there has been a previous report received in the past two years where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are...show all
Description of Event or Problem: In this event it was reported that a palodent plus placement forceps broke during use; no injury resulted.
Description of Event or Problem: The facility initially reported a patient swallowed a mirror. The patient was taken to the hospital for x-ray. Spoke with dental hygienist who reported that she was working on back tooth #32 when the patient, who was said to be physically challenged, but down on the mirror. The patient swallowed...show all
Additional Manufacturer Narrative: The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Description of Event or Problem: During surgical procedure, physician was utilizing elevator to remove tooth. The tip of the instrument broke during the procedure. Physician retreived the tip and ensured no harm was done to the patient.====================== health professional's impression======================unknown.
2009-12-29 BIOHORIZONS PRA(No full report available)
Description of Event or Problem: In 2009, the clinician reported that while placing an implant into the pt, the pt aspirated the pra (internal ratchet & hand wrench adapter). Pt was taken to a hosp where surgery was performed to remove the instrument from the pt's left lung. The next day, biohorizons was informed by...show all
Additional Manufacturer Narrative: The pra was part of the internal surgical kit (lot# 0802204); kits were assembled using multiple lot numbers of the pra (lots po0003238, 09070113, and 01080129), and the actual lot # of the pra instrument involved could not be determined. The instrument was not returned for eval, and no items...show all
2009-12-29 BIOHORIZONS 300-205(No full report available)
Description of Event or Problem: In 2009, the clinician reported that while placing an implant into the pt, the pt aspirated the pra (internal ratchet & hand wrench adapter). Pt was taken to the hosp, where surgery was performed to remove the instrument from the pt's left lung. The following day, biohorizons was informed by...show all
Additional Manufacturer Narrative: The instrument was not returned for eval, and no items 300-205 of the same lot # remained in stock. Functional interface shake testing was performed on ten (10) units of 300-205 (lot# 0901745) from inventory in 2009; 10/10 units remained secured in the test ratchet, even with vigorous shaking, and...show all
2009-11-11 *(No full report available)
Description of Event or Problem: Upon picking up dental instrument after use on patient, it was apparent that the tip was missing. surgeon was notified and visual inspection did not reveal or find the missing piece. x-ray taken and supervisor notified x-ray read and missing tip of instrument was not identified on x-ray...show all
Description of Event or Problem: Upon picking up dental instrument after use on patient, it was apparent that the tip was missing. surgeon was notified and visual inspection did not reveal or find the missing piece. x-ray taken and supervisor notified x-ray read and missing tip of instrument was not identified on x-ray...show all
2009-04-23 PIEZOSURGERY(No full report available)
Description of Event or Problem: While using an oral surgery device on the patient, the diamond head tip broke off and was immediately suctioned and located.
2008-02-06 BONE PACKER(No full report available)
Description of Event or Problem: The dentist used the innovative implant technology's (iit) bone packer instrument to pack the bone graft material underneath the elevated maxillary sinus membrane. The head of the bone packer got stuck in the area below the elevated sinus membrane. Upon pulling the bone packer, the distal portion of the bone...show all
Additional Manufacturer Narrative: Conclusion: the instrument performed as designed, with the initial break on the handle at the proximal end of the curette tube, between the elbow and the curette tube junction. The second break at the packer head was due to excessive tensile force during the removal of the packer from the...show all
2006-08-29 TREPHINE DRILL 5.2/6.2MM(No full report available)
Description of Event or Problem: Note: based upon information provided by the initial reporter. While removing the implant with trephine drill, the trephine drill changed shape and caused a lip laceration and a tear in the right floor to the mouth lateral tongue.
2006-08-29 (No full report available)
Additional Manufacturer Narrative: Requested part and no part was returned to nobel biocare for eval. No lot number was provided for lot tracking. Requested pt info, date of event, case details and it was not provided to nobel biocare. This is the first report of this type rec'd for the reported part number...show all
2003-01-28 ART GLASS - HERAEUS KULZER(No full report available)
Description of Event or Problem: Dental pt had an "art glass" to metal crown on their lower right first premolar placed in 7/1997. The art glass material debonded in 2001, requiring replacement of the crown with a more suitable material. Had this not been done, the tooth would have super erupted, possibly requiring replacement.
2002-12-10 ARTGLASS(No full report available)
Description of Event or Problem: Reporter placed three artglass crowns for a pt. They were made by a laboratory and were fabricated with high noble gold. These crowns were made of artglass and were reputed to be of the finest material and very quickly, within one year serious problems developed which led to the replacement...show all
2002-12-06 HERAEUS KULZER(No full report available)
Description of Event or Problem: The art glass crowns, chipped, broken, fell off teeth, they required a special cement that failed, the crowns themselves had no luster or polish. Repeated calls to kulzer's lab tech support did not improve the problems.
2002-11-21 ARTGLASS(No full report available)
Description of Event or Problem: Devices are fracturing very easily and debonding (coming off of the teeth).
2002-11-19 ART GLASS(No full report available)
Description of Event or Problem: While materical debonds form the metal substructure and dissappears / wears out way too fast. Pt just had a 5 unit bridge cut off and replaced: bridge started chipping almost immediately.
2002-11-12 ART GLASS(No full report available)
Description of Event or Problem: Rptr did over 100 dental restorations and had to replace them all. They either chipped or fractured. The devices had no wear or biting tolerance and lasted no more than a year. Rptr lost their practice over this. Device was advertised that it's better than porcelain and was easy to...show all
2002-11-11 KULZER ARTGLASS(No full report available)
Description of Event or Problem: Kulzer's artglass failures. From a year after cementation until today rptr has redone close to 400 crowns.
2002-11-11 ARTGLASS & KEVLOC OR SILOC(No full report available)
Description of Event or Problem: Problems with artglass metal units. Survival rate of 25% after 5 years. Artglass dental products are defective and unreasonably dangerous. All rptr's pts with artglass-metal units having problems. Rptr has spent hrs and hrs to repair fractured artlass units. Some pts lost their dental implants.
2002-11-07 ART GLASS(No full report available)
Description of Event or Problem: Premature breakage.
2002-11-07 SCULPTURE(No full report available)
Description of Event or Problem: Breakage in the mouth. Device will break from one year or less however it was advertised as being very strong. Mfr was notified of breakages but mfr was unable to answer this. Mfr was asked if another device (fibercore) should be used with the device but they said that would...show all
2002-11-07 ARTGLASS(No full report available)
Description of Event or Problem: Fail prematurely. They fall off of the metal. Rptr has had 40-50 pts affected where the crowns have had to be replaced. Dental lab used has this well documented with multiple dentists.
2002-11-06 ARTGLASS(No full report available)
Description of Event or Problem: Rptr placed a number of artglass dental restorations which failed in relatively short order and which they replaced at no charge to their pts. Rptr was reimbursed a nominal amount due to the defective nature of the restorations, but feels kulzer did not adequately inform the dental profession of the...show all
2002-10-31 ARTGLASS(No full report available)
Description of Event or Problem: Rptr read in a dental magazine that there is a class action suit stating that this was placed on the market before it was adequately proved to be a viable product. Rptr has experienced 156 failures with one dentist. The teeth made and inserted into pts' mouths either broke or...show all
2002-10-31 ARTGLASS(No full report available)
Description of Event or Problem: The crowns failed. There were many remakes costing lots of money and "chair time". Rptr did receive a settlement for their problems.
2002-10-31 ART GLASS(No full report available)
Description of Event or Problem: During the past 3 1/2 years the art glass restoration has popped off twice. Now the margins are cracked/chipped and the while restoration has appeared to have shrunk. The color stability is poor. The restoration must be replaced.
2002-10-30 ARTGLASS(No full report available)
Description of Event or Problem: Artglass dental restorations where placed on approx 30 pts in dental practice over a period of several mos in 1997 and 1998. Dentist saw a failure rate of nearly 100% (breakage) during the ensuing 3-4 years. Dentist has just read of fda's warning to kulzer regarding non-conformance with the code...show all
1997-01-02 GUIDER BIORESORBABLE MATRIX BARRIER(No full report available)
Description of Event or Problem: Allograft demineralized bone was placed lot #96-0250b-225; sutures used for closure; co's device placed on #5, #18, #19, #31; pt was a smoker, materials placed on 10/14; antibiotic were used for 2 weeks, doxycycline then "cleosine". 10/21; swelling and exudate; 10/29; palatal swelling -device removed from #5; 11/4: debridement; 11/8/:...show all
1995-05-23 GUIDOR BIORESORBABLE MATRIX BARRIER(No full report available)
Description of Event or Problem: Pt noted painless swelling approx 3 months after placement of product in right anterior maxilla to cover autogenous bone graft over a dental implant. This swelling persisted and was drained on 1/3/95 without any foreign body found. Swelling returned within 1 month.
1995-05-23 GUIDOR BIORESORBABLE MATRIX BARRIER(No full report available)
Description of Event or Problem: Pt presented with painless swelling of 1-2 week duration in area of surgical site. Exploration revealed abscess in area product placed, and loss of bone graft. (autogenous bonegraft around dental implant in left mandible was covered by product).
1995-05-23 GUIDOR BIORESORBABLE MATRIX BARRIER(No full report available)
Description of Event or Problem: Re-entry into surgical site (right mandible) where previously placed bone graft (bio-oss-cancellous and organic bovine bone) and dental implant were covered by product (bioresorbable matrix barrier for tissue regeneration) revealed partial resorption of bone graft. Prior to re-entry, clinical signs of fluctuating swelling of site noticed from approx 6 weeks...show all
1995-05-23 GUIDOR BIORESORBABLE MATRIX BARRIER(No full report available)
Description of Event or Problem: Re-entry into surgical site (anterior maxilla) where previously-placed autogenous bone graft covered with product (bioresorbable matrix barrier for tissue regeneration) revealed abscess formation with partial resorption of bone graft.
1994-06-03 GUIDOR PERIDONTAL MATERIAL(No full report available)
Description of Event or Problem: Pt presented with acute pain in area where periodontal regeneration procedure had been done with device material. Surgical re-entry demonstrated resorption of root.