MAUDE Adverse Event Report: SYNTHES GMBH T-PAL SPACER 10MM X 28MM 9MM HEIGHT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	08.812.009S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Type of Reportable Event	Serious Injury
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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.H6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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
Device report from japan reports an event as follows: it was reported that patient underwent a surgery on (b)(6), 2018.Patient underwent extended re-fusion surgery on december 18, 2023, due to adjacent intervertebral disorders.Transforaminal lumbar interbody fusion (tlif) was performed on l2/3 and extended.Posterior lumbar interbody fusion (plif) was performed on l1/2.It is confirmed l4/5 achieved osteosynthesis.This report is for a t-pal spacer 10mm x 28mm 9mm height.This is report 2 of 2 for (b)(4).Additional reports are captured under (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h4,h6 part # 08.812.009s lot # l693594 manufacturing site: werk hagendorf release to warehouse date : 30 jan 2018 expiration date:n/a supplier: n/a 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 9MM HEIGHT
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES HAEGENDORF; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18475722
• Report Number: 8030965-2024-00478
• Device Sequence Number: 6426711
• Product Code: MAX
• UDI-Device Identifier: 10705034759548
• UDI-Public: (01)10705034759548
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 08.812.009S
• Device Lot Number: L693594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: T-PAL SMALL CAGE H7 PEEK.; UNK - LOCKING/SET SCREWS.; UNK - LOCKING/SET SCREWS.; UNK - RODS: SPINE.; UNK - RODS: SPINE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown