IFUSE IMPLANT SYSTEM
Received Sep 15, 2021 · Event occurred Aug 24, 2021
Report 3007700286-2021-00094 · MDR key 12478678
Device
Product problems
- Loss of Osseointegration
- Loss of Osseointegration
Patient
60 YR
- Arthralgia
- Arthralgia
Narrative
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU AND FMEA, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS IMPLANT LATE LOOSENING.
Description of Event or Problem
THE PATIENT HAD RIGHT SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE INITIAL PROCEDURE DATE IS NOT KNOWN. THE PATIENT LATER REPORTED A RECURRENCE OF SI JOINT PAIN. THE SURGEON DETERMINED THAT THE IMPLANTS MAY HAVE BEEN LOOSE. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED ALL THREE IMPLANTS USING CHISELS. HE THEN INSTALLED NEW HARDWARE IN EACH OF THE EXPLANT VOIDS. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.