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

Catalog Number 08.812.011S

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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 history lot - 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that, on (b)(6) 2018, the primary fusion procedure (l4-sai) was performed with the t-pal cage in question and non j&j¿s screws.It was found that the cage had came off and the patient re-suffered from stenosis.On (b)(6) 2021, the patient underwent the plif revision procedure (l5/s) and the lesion was decompressed.Originally the surgeon planned to remove the cage, but bone fusion was attained.So he ground the bone around the cage, released pressure to the nerve and left the cage in the patient¿s body.Procedure was completed without surgical delay.This report is for one (1) t-pal spacer 10mm x 28mm 11mm height.This is report 1 of 1 for complaint (b)(4).

• Brand Name: T-PAL SPACER 10MM X 28MM 11MM HEIGHT
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• 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: 12571671
• MDR Text Key: 274602543
• Report Number: 8030965-2021-08341
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07611819405677
• UDI-Public: (01)07611819405677
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08.812.011S
• Device Lot Number: L567363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2017
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention