MAUDE Adverse Event Report: SYNTHES GMBH T-PAL SPACER 10MM X 28MM 11MM HEIGHT; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number	08.812.011
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.
Event or Problem Description
It was reported that on an unknown date, the patient had an l4/5 (tlif) transforaminal lumbar interbody fusion done 8-10 weeks ago using a tpal spacer.During a post-operative visit to the clinic looking at x-rays.The surgeon noticed the spacer had migrated posteriorly and would need to be removed.Procedure outcome and patient status are unknown.This complaint involves one (1) device.This report is for (1) t-pal spacer 10mm x 28mm 11mm height.This is report 1 of 1 for complaint (b)(4).
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.H3, h4, h6- the part had migrated from implanted position, and it was confirmed from the x-rays.During investigation, a definitive assignable root cause could not be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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: 08.812.011, lot: 5l24192, manufacturing site: hagendorf, supplier: n/a, release to warehouse date: 17 july 2019, expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.,part: 08.812.011.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: T-PAL SPACER 10MM X 28MM 11MM HEIGHT
• Common Device Name: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; karolingerstrasse 16; salzburg 5020 ; AU 5020
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12900386
• Report Number: 8030965-2021-09839
• Device Sequence Number: 4739948
• Product Code: MAX
• UDI-Device Identifier: 10705034759562
• UDI-Public: (01)10705034759562
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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 Model Number: 08.812.011
• Device Catalogue Number: 08.812.011
• Device Lot Number: 5L24192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female