MalfunctionGXN
ACCUSHAPE PEEK
Received Mar 3, 2026 · Event occurred Feb 4, 2026
Report 3009196021-2026-00005 · MDR key 24502978
Device
Product problems
- Difficult or Delayed Positioning
- Positioning Failure
Patient
79 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MODIFICATION TO THE POSTERIOR END OF DEVICE WAS REQUIRED IN ORDER TO MAKE THE DEVICE SIT FLUSH. SURGEON WAS SATISFIED WITH THE RESULTS.
Description of Event or Problem
PEEK IMPLANT DID NOT SIT FLUSH.