IFUSE IMPLANT SYSTEM
Received May 19, 2021 · Event occurred Apr 28, 2021
Report 3007700286-2021-00053 · MDR key 11849941
Device
Product problems
- Malposition of Device
- Malposition of Device
Patient
48 YR
- Undesired Nerve Stimulation
- Undesired Nerve Stimulation
Narrative
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, 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."
Description of Event or Problem
THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF LEG PAIN THE FOLLOWING DAY. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. ONE WEEK AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE THE INFERIOR POSITIONED IMPLANT WAS REMOVED. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. NO NEW HARDWARE WAS ADDED. IT IS NOT KNOWN IF BONE GRAFT WAS PLACED IN THE EXPLANT VOID. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.