IFUSE IMPLANT SYSTEM
Received Oct 1, 2021 · Event occurred Sep 3, 2021
Report 3007700286-2021-00096 · MDR key 12566166
Device
Product problems
- Malposition of Device
- Malposition of Device
Patient
62 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: IMPLANT MALPOSITIONING. 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 LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED, ONE ROD AND TWO SCREWS). THE PATIENT LATER COMPLAINED OF LEG AND GROIN PAIN. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED ROD WAS BREACHING ANTERIORLY CAUSING L5 NERVE ISSUES BASED ON CT RESULTS. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT ROD AND REINSTALLED IT IN A NEW TRAJECTORY. THE PATIENT'S PAIN COMPLAINTS RESOLVED FOLLOWING THE REVISION PROCEDURE.