MAUDE Adverse Event Report: SYNTHES GMBH T-PAL ADVANCED APPLICATOR INNER SHAFT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 03.812.521

Device Problem Compatibility Problem (2960)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales representative.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the t-pal advanced applicator inner shaft was unable to collect the unknown parts as intended.There was no surgical delay.The procedure outcome and patient status were completed successfully.This report is for 1 t-pal advanced applicator inner shaft.This is report 1 of 1 for (b)(4).

Event Description

The initial complaint was reviewed and found to be a duplicate of (b)(4).Information has already been reported under manufacturer report number 8030965-2021-03061.

• Brand Name: T-PAL ADVANCED APPLICATOR INNER SHAFT
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11921057
• MDR Text Key: 253761986
• Report Number: 8030965-2021-04469
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07612334143785
• UDI-Public: (01)07612334143785
• Combination Product (y/n): N
• PMA/PMN Number: K181231
• 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: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.521
• Device Lot Number: L916575
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2021
• Patient Sequence Number: 1