IFUSE IMPLANT SYSTEM

Description of Event or Problem

THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2015 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED TO A NEW SURGEON WITH COMPLAINTS OF A RECURRENCE OF SI JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE MIDDLE AND INFERIOR POSITIONED IMPLANTS WERE NOT POSITIONED FULLY ACROSS THE SI JOINT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED MIDDLE AND INFERIOR POSITIONED IMPLANTS USING CHISELS AND REPLACED THEM WITH A LONGER IMPLANT OF THE SAME TYPE THAT WAS INSTALLED IN A NEW POSITION ACROSS THE SI JOINT. THE PREEXISTING SUPERIOR POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

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 DEVICES WERE OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS USER ERROR: IMPROPER IMPLANT SIZE SELECTION, USING AN IMPLANT THAT WAS TOO SHORT, OR NOT INSTALLING THE IMPLANT FULLY ACROSS THE SI JOINT. 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: 2ND (MIDDLE): IFUSE IMPLANT, P/N 7050-90, LOT# 493349, MFD. 07/20/15, EXPIRES 2020-07, (B)(4). 3RD (INFERIOR): IFUSE IMPLANT, P/N 7045-90, LOT# 353339, MFD. 04/07/15, EXP. 2020-04-07, (B)(4).