IFUSE IMPLANT SYSTEM
Received Nov 29, 2021 · Event occurred Nov 1, 2021
Report 3007700286-2021-00125 · MDR key 12887993
Device
Product problems
- Malposition of Device
- Malposition of Device
Patient
75 YR · Female
- Undesired Nerve Stimulation
- Undesired Nerve Stimulation
Narrative
Description of Event or Problem
THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF LEG/FOOT PAIN POST-SURGERY DURING RECOVERY. THE SUPERIOR IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. SAME DAY, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE SUPERIOR-POSITIONED IMPLANT. NO BONE GRAFT OR ADDITIONAL HARDWARE WAS ADDED. NONE OF THE 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 IS USER ERROR: USING TOO LONG OF AN IMPLANT OR INSTALLING THE IMPLANT TOO DEEP. ADDITIONALLY, PER THE SURGICAL TECHNIQUE MANUAL (C-ARM AND O-ARM), 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."