MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH POST IBF UI H 10MM 4DEG 26/9; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	PUI41006
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, patient underwent a tlif spinal procedure (date unknown) and some point afterward the tlif spacer extruded posteriorly into the spinal canal.Patient returned to the surgeon complaining of left leg pain.Upon x-ray, the mal-positioned spacer was discovered and a revision surgery was scheduled.On (b)(6) 2022 patient underwent an alif procedure to remove the tlif spacer and replace with a synfix alif stand-alone spacer.This report is for one (1) post ibf ui h 10 mm 4deg 26/9.This is report 1 of 1 for complaint: (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the photo revealed that the post ibf ui h 10 mm 4deg 26/9 moved posteriorly from where it was previously implanted.The reported event of migration can be confirmed with the evidence provided.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for post ibf ui h 10 mm 4deg 26/9, pui41006 there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 lot: part # pui41006, lot # e21la0755, release to warehouse date: 08 oct 2021 supplier: (b)(4).No ncr's were generated during production.Device was used for treatment, not diagnosis.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 10MM 4DEG 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; DE D-78573
• Manufacturer (Section G): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; DE
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15121201
• Report Number: 3013730328-2022-00063
• Device Sequence Number: 14864442
• Product Code: MAX
• UDI-Device Identifier: 04260557778517
• UDI-Public: (01)04260557778517
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PUI41006
• Device Catalogue Number: PUI41006
• Device Lot Number: E21LA0755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male