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 FOR THE IMPLANT LOOSENING IS THE PATIENT'S FALL. PART NUMBER, LOT NUMBER, MANUFACTURING DATE, EXPIRATION DATE AND GTIN NUMBER: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7050-90, LOT# 7753002898005, MFD. 11/04/11, EXP. 2014-11-04, GTIN (B)(4). 2ND (SECOND): IFUSE IMPLANT, P/N 7040-90, LOT# 8028003323003, MFD. 05/08/12, EXP. 2015-05-08, GTIN (B)(4). 3RD (INFERIOR): IFUSE IMPLANT, P/N 7040-90, LOT# 8028003323003, MFD. 05/08/12, EXP. 2015-05-08, GTIN (B)(4).

Description of Event or Problem

THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2012 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR EIGHT YEARS BEFORE COMPLAINING OF A RECURRENCE OF SI-JOINT PAIN SYMPTOMS AFTER A FALL. THE SURGEON DETERMINED THAT THE SUPERIOR AND INFERIOR POSITIONED IMPLANTS WERE LOOSE ON THE SACRAL SIDE. THE IMPLANTS LIKELY LOOSENED AFTER THE PATIENT FELL. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED ALL THREE INITIAL IMPLANTS USING CHISELS AS THEY WERE ALL SOLIDLY FIXED IN BONE. HE REPLACED THEM WITH THREE LARGER IMPLANTS OF THE SAME TYPE. THE PATIENT IS DOING WELL FOLLOWING THE REVISION PROCEDURE.