IFUSE IMPLANT SYSTEM

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU, CERTIFICATES OF ANALYSIS AND FMEA, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE FOR THE RECURRENCE OF PAIN IS THE PATIENT'S FALL. 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 UDI/GTIN NUMBER IF APPLICABLE: 1ST (CRANIAL): IFUSE IMPLANT, P/N 7050-100, LOT# 494372, MFD. 03 NOV 18, EXP. 2023-11-03, (B)(4). 2ND (MIDDLE): IFUSE IMPLANT, P/N 7060-100, LOT# 494465, MFD. 20 FEB 19, EXP. 2023-12-14, (B)(4). 3RD (CAUDAL): IFUSE IMPLANT, P/N 7040-100, LOT# 494529, MFD. 25 FEB 19, EXP. 2024-02-25, (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 DID WELL AFTER THE INITIAL PROCEDURE BUT LATER COMPLAINED OF A RECURRENCE OF LEFT SI JOINT PAIN AFTER A FALL. THE SURGEON DECIDED TO REMOVE AND REPOSITION THE IMPLANTS FOR BETTER STABILIZATION. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED ALL THREE IMPLANTS USING CHISELS AND FILLED THE EXPLANT VOIDS WITH BONE GRAFT. HE THEN INSTALLED THREE NEW IMPLANTS OF THE SAME TYPE IN MORE OPTIMAL POSITIONS. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.