IFUSE IMPLANT SYSTEM
Received Oct 20, 2021 · Event occurred Sep 21, 2021
Report 3007700286-2021-00107 · MDR key 12667131
Device
Product problems
- Malposition of Device
- Adverse Event Without Identified Device or Use Problem
- Malposition of Device
- Adverse Event Without Identified Device or Use Problem
Patient
57 YR
- Undesired Nerve Stimulation
- Undesired Nerve Stimulation
Narrative
Description of Event or Problem
THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED ON EACH SIDE. THE PATIENT LATER COMPLAINED OF CONTINUED SI JOINT PAIN. THE PATIENT REPORTED RIGHT SIDE LEG PAINS FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DID NOT DETERMINE THAT ANY OF THE RIGHT SIDE IMPLANTS WERE MALPOSITIONED BUT DECIDED TO REMOVE THE RIGHT SIDE SUPERIOR POSITIONED IMPLANT REGARDLESS. TWO WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE RIGHT SIDE SUPERIOR POSITIONED IMPLANT. THE EXPLANT VOID WAS NOT FILLED WITH BONE GRAFT OR OTHER HARDWARE. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU, CERTIFICATES OF CONFORMANCE AND FMEA, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED, BUT IT IS POSSIBLE THAT AN IMPLANT MAY HAVE BEEN MALPOSITIONED AND WAS IMPINGING ON THE NERVE CAUSING LEG PAIN. MALPOSITIONING AND/OR USING TOO LONG OF AN IMPLANT IS USE ERROR. ADDITIONALLY, PER THE SURGICAL TECHNIQUE MANUAL, THE SURGEON IS INSTRUCTED AS FOLLOWS: "PRIOR TO CLOSURE, ALWAYS OBTAIN FINAL FLUOROSCOPIC IMAGES IN THE LATERAL, INLET, AND OUTLET VIEWS TO CONFIRM NO CORTICAL WALL BREACH, FORAMEN BREACH, OR OTHER MALPOSITION."