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: USING TOO LONG OF AN 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." PART NUMBER, LOT NUMBER, MANUFACTURING DATE, EXPIRATION DATE AND GTIN NUMBER: 1ST (SUPERIOR): IFUSE-3D IMPLANT, P/N 7065M-90, LOT# 2762831, MFD. 09/29/20, EXP. 2025-09-29, (B)(4). 3RD (INFERIOR): IFUSE-3D IMPLANT, P/N 7035M-90, LOT# 2765031, MFD. 12/01/20, EXP. 2025-12-01, (B)(4).

Description of Event or Problem

THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED RADICULAR PAIN SYMPTOMS. THE SURGEON DETERMINED BASED ON THE IMAGING THAT THE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. HE ALSO REMOVED THE INFERIOR POSITIONED IMPLANT AND PACKED THE EXPLANT VOID WITH BONE GRAFT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S RADICULAR PAIN SYMPTOMS DID NOT RESOLVE FOLLOWING THE REVISION PROCEDURE.