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: MALPOSITIONING OF THE IMPLANT. 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 FOOT PAIN AFTER THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS MALPOSITIONED, PLACED TOO ANTERIORLY. FIVE DAYS 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 TO THE EXPLANT VOID. HE THEN INSTALLED A NEW, SHORTER, IMPLANT OF THE SAME TYPE IN A MORE POSTERIOR POSITION. NONE OF THE OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.