IFUSE IMPLANT SYSTEM

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: INSTALLING THE IMPLANTS 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." PART NUMBER, LOT NUMBER, MANUFACTURING DATE, EXPIRATION DATE AND GTIN: 1ST (SUPERIOR): IFUSE-3D IMPLANT, P/N 7060M-90, LOT# 2691991, MFD. 08/01/19, EXP. 2024-08-01, GTIN (B)(4). 2ND (MIDDLE): IFUSE-3D IMPLANT, P/N 7055M-90, LOT# 2676741, MFD. 04/11/19, EXP. 2024-04-11, GTIN (B)(4).

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 PAIN TWO DAYS AFTER THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR AND MIDDLE POSITIONED IMPLANTS WERE IMPLANTED TOO DEEP AND HAD BREACHED THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE BACKED-UP, BUT DID NOT REMOVE, THE SUPERIOR AND MIDDLE POSITIONED IMPLANTS A FEW MILLIMETERS EACH TO RELIEVE THE NERVE IMPINGEMENT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.