IFUSE IMPLANT SYSTEM
Received Apr 1, 2022 · Event occurred Mar 4, 2022
Report 3007700286-2022-00002 · MDR key 13984937
Device
Product problems
- Malposition of Device
- Malposition of Device
Patient
41 YR · Female
- Undesired Nerve Stimulation
- Undesired Nerve Stimulation
Narrative
Description of Event or Problem
THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2022 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. DURING THE INITIAL PROCEDURE, THE SURGEON HAD REMOVED THE GUIDE PIN DUE TO PIN ADVANCEMENT AND IMPACTED THE IMPLANT INTO POSITION WITHOUT USING ANY GUIDE PIN AT ALL. DURING INSTALLATION, THE IMPLANT DID NOT FOLLOW THE PRESCRIBED PATH. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. THE DAY AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE 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 USE ERROR: THE SURGEON DID NOT FOLLOW THE RECOMMENDED IMPLANT INSTALLATION PROCEDURE. 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."