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 DEVICES WERE OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS USER ERROR: IMPROPER IMPLANT SIZE SELECTION, USING IMPLANTS THAT WERE TOO SHORT. 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 NUMBER: 2ND (MIDDLE): IFUSE IMPLANT, P/N 7040-100, LOT# 494533, MFD. 06 MAY 19, EXP. 2024-05-06, GTIN (B)(4). 3RD (CAUDAL): IFUSE IMPLANT, P/N 7035-100, LOT# 494422, MFD. 14 NOV 18, EXP. 2023-11-14, GTIN (B)(4).

Description of Event or Problem

IN (B)(6) 2020, THE PATIENT HAD RIGHT SI JOINT ARTHRODESIS WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF CONTINUED SI JOINT PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE MIDDLE AND CAUDAL POSITIONED IMPLANTS WERE TOO SHORT AND WERE NOT FULLY ACROSS THE SI JOINT. APPROXIMATELY THREE WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED BOTH THE MIDDLE AND CAUDAL POSITIONED IMPLANTS AND REPLACED THEM WITH LONGER IMPLANTS OF THE SAME TYPE USING THE EXPLANT VOIDS. THE PREEXISTING CRANIAL POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE PATIENT'S SI JOINT PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.