MAUDE Adverse Event Report: SYNTHES GMBH T-PAL LARGE H7 PEEK; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 08.812.207S

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that a t-pal peek l cage was implanted in the l4-l5 interbody segment.When it was pushed more with the help of the implant impactor instrument, the back part of the cage broke.The broken pieces were removed under microscope control with help of a long clamp.The anterior part of the cage could not be removed so the anterior intact part was pushed more anteriorly under microscope control.This expanded the interbody space and appeared as good as a regular full shaped cage.There was a surgical delay of fifteen (15) minutes and the procedure was completed successfully.Concomitant device reported: unknown impactor (part# unknown, lot# unknown, quantity 1).This report is for one (1) t-pal large h7 peek.This is report 1 of 1 for (b)(4).

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.H6: a device history record (dhr) review was conducted: part: 08.812.207s, lot: 5l34827, manufacturing site: hägendorf, release to warehouse date: 31.Jul.2019, expiry date: 01.Jul.2029.A manufacturing record evaluation was performed for the finished device lot number, 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 LARGE H7 PEEK
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10871117
• MDR Text Key: 217434584
• Report Number: 8030965-2020-09090
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• PMA/PMN Number: K100089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08.812.207S
• Device Lot Number: 5L34827
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2021
• Patient Sequence Number: 1
• Treatment: UNK - IMPACTION INSTRUMENTS: SPINE
• Patient Age: 44 YR
• Patient Weight: 90