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, INITIAL IMPLANT MALPOSITIONING. 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." IMPLANT PART NUMBER, LOT NUMBER, MANUFACTURE DATE, EXPIRATION DATE, GTIN 1ST (SUPERIOR): IFUSE-3D IMPLANT, P/N 7050M-100, LOT# 2641551, MFD.06/12/18, EXP. 2023-06-12, GTIN 00851085007497. 2ND (MIDDLE): IFUSE-3D IMPLANT, P/N 7035M-100, LOT# 2692001, MFD. 08/01/19, EXP. 2024-08-01, GTIN 00851085007466. 3RD (INFERIOR): IFUSE-3D IMPLANT, P/N 7035M-100, LOT# 2641521, MFD. 06/12/18, EXP. 2023-06-12, GTIN 00851085007466.

Description of Event or Problem

THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE MOST CAUDAL POSITIONED IMPLANT WAS REMOVED LATER THAT SAME DAY FOR BEING MALPOSITIONED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR THREE TO SIX MONTHS BEFORE REPORTING TO A NEW SURGEON WITH COMPLAINTS OF A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON SUSPECTED THAT THE IMPLANTS MAY HAVE BEEN LOOSE, AND THAT THE MIDDLE IMPLANT WAS NOT ACROSS THE SI JOINT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE FIRST REMOVED THE MIDDLE IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. THE EXPLANT VOID WAS FILLED WITH BONE GRAFT. HE THEN INSTALLED TWO ILIOSACRAL SCREWS. THE INITIAL CRANIAL POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE PATIENT'S PAIN WAS REDUCED IMMEDIATELY POST-OP.