IFUSE IMPLANT SYSTEM

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, CERTIFICATES OF ANALYSIS, IFU 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 INITIAL IMPLANTS. 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 (CRANIAL): IFUSE IMPLANT, P/N 7050-100, LOT# 494293, MFD. 19 FEB 18, EXP. 2023-02-19, GTIN (B)(4). 2ND (MIDDLE): IFUSE IMPLANT, P/N 7040-100, LOT# 494533, MFD. 06 MAY 19, EXP. 2024-05-06, GTIN (B)(4).

Description of Event or Problem

IN (B)(6) 2021 THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED LEFT SIDE RADICULAR PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE CRANIAL AND MIDDLE POSITIONED IMPLANTS WERE MALPOSITIONED AND IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. ONE WEEK AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT AND RE-IMPLANTED IT IN A MORE CRANIAL POSITION AND REMOVED THE MIDDLE IMPLANT. FINALLY, AN ADDITIONAL IMPLANT WAS ADDED IN A NEW POSITION BELOW THE PREEXISTING CAUDAL IMPLANT. THE PREEXISTING CAUDAL POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.