ARTHREX, INC. SP FBRTAK RC TGRTPE WH/BLK & STTPE WH/BL; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
|
Back to Search Results |
|
Model Number SP FBRTAK RC TGRTPE WH/BLK & STTPE WH/BL |
Device Problem
Device Slipped (1584)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 06/21/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
|
|
Event Description
|
On(b)(6) 2022, it was reported by a sales representative via phone that an ar-3652sp fibertak pulled out of implantation site and created a bigger bone socket.Surgeon used a 6.25 swivelock to complete the case.This was discovered during an rcr on (b)(6) 2022.
|
|
Search Alerts/Recalls
|
|
|