MalfunctionGXN
ACCUSHAPE PEEK
Received Apr 17, 2026 · Event occurred Apr 1, 2026
Report 3009196021-2026-00009 · MDR key 24913032
Device
Product problems
- Failure to Clean Adequately
Patient
77 YR · Male
- Failure of Implant
Narrative
Additional Manufacturer Narrative
MEDCAD EVALUATED THE DEVICE AND DETERMINED THAT THE OBSERVED SHEEN ORIGINATED FROM THE MACHINING PROCESS. ADDITIONALLY, THE FEW DRAINAGE HOLES WERE FOUND TO CONTAIN PEEK MATERIAL. SURGEON WAS ABLE TO RE-SCHEDULE THE SURGERY, AND A NEW IMPLANT ALONG WITH A DUPLICATE IMPLANT, WAS PROVIDED BEFORE THE RESCHEDULED SURGERY DATE UPON CONFORMANCE.
Description of Event or Problem
PEEK IMPLANT HAD SHEEN ON IT AND DRAINAGE HOLES WERE NOT CLEANED ALL THE WAY THROUGH.
Remedial action
- Replace