MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH POST IBF UI H 12MM 18DEG 26/9; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	PUI91206
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2024 during a tlif the surgeon tried to twist a conduit 12mm ht cage and felt a crunch.It was discovered through x-ray that the implant broke.The damaged implant and all pieces were removed and a new cage was placed.The procedure was successfully completed with a surgical delay of 20 minutes.There was generation of fragments which were removed without any additional intervention.The x ray was taken to confirm that all the pieces were removed.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: h6: the product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed that the post ibf ui h 12mm 18deg 26/9 was observed broken and bending.No other issues were observed.Therefore, the reported condition can be confirmed.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces.According to the ifu 090290201, implants can break when subjected to the increased loading associated with delayed union or nonunion.The implant can fail due to excessive load, wear and tear, or infection.Internal fixation devices are load-sharing devices that are used to obtain an alignment until normal healing occurs.If healing is delayed, or does not occur, the implant may eventually break due to material fatigue.The degree of success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the device.Notches, scratches, or bending of the implant during the course of surgery may also contribute to early failure.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the post ibf ui h 12mm 18deg 26/9 would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: part # pui91206.Lot # e21la0572.Supplier: (b)(4).Batch1: lot qty of (b)(4) units were released on 02 aug 2021 with no discrepancies.No ncrs were generated during production.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: h3, h4, h6: photo investigation: the product was not returned to j&j medtech orthopaedics; however photos were provided for review.The photo investigation revealed that the post ibf ui h 12mm 18deg 26/9 was observed broken and bending.No other issues were observed.Therefore, the reported condition can be confirmed.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces.According to the ifu 090290201, implants can break when subjected to the increased loading associated with delayed union or nonunion.The implant can fail due to excessive load, wear and tear, or infection.Internal fixation devices are load-sharing devices that are used to obtain an alignment until normal healing occurs.If healing is delayed, or does not occur, the implant may eventually break due to material fatigue.The degree of success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the device.Notches, scratches, or bending of the implant during the course of surgery may also contribute to early failure.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the post ibf ui h 12mm 18deg 26/9 would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Physical device investigation: the product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that post ibf ui h 12mm 18deg 26/9 was broken in three sections and the surface of the implant is bent, ikely caused due to excessive twist during the procedure.No issues related to material were identified.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces.According to the ifu 090290201, implants can break when subjected to the increased loading associated with delayed union or nonunion.The implant can fail due to excessive load, wear and tear, or infection.Internal fixation devices are load-sharing devices that are used to obtain an alignment until normal healing occurs.If healing is delayed, or does not occur, the implant may eventually break due to material fatigue.The degree of success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the device.Notches, scratches, or bending of the implant during the course of surgery may also contribute to early failure.A dimensional inspection for the post ibf ui h 12mm 18deg 26/9 was not performed due to post manufacturing damage.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the post ibf ui h 12mm 18deg 26/9 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review (dhr): part # pui91206 lot # e21la0572 supplier: (b)(4).Batch 1: lot qty of (b)(4) units were released on 02 aug 2021 with no discrepancies.No ncrs were generated during production.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: POST IBF UI H 12MM 18DEG 26/9
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73
• Manufacturer (Section G): EIT EMERGING IMPLANT TECHNOLOGIES GMBH
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 20557661
• Report Number: 3013730328-2024-00064
• Device Sequence Number: 18367268
• Product Code: MAX
• UDI-Device Identifier: 04260557821169
• UDI-Public: (01)04260557821169(10)E21LA0572
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K170503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PUI91206
• Device Lot Number: E21LA0572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 11/14/2024; 11/20/2024; 12/09/2024; 12/12/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/19/2024; 11/21/2024; 12/11/2024; 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male