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: IMPROPER IMPLANT SIZE SELECTION, USING AN IMPLANT THAT WAS TOO SHORT, OR NOT INSTALLING THE IMPLANT DEEP ENOUGH. 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."

Description of Event or Problem

IN (B)(6) 2019, THE PATIENT HAD LEFT SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR A FEW WEEKS BEFORE FOLLOWING THE INITIAL PROCEDURE BUT LATER REPORTED A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS NOT POSITIONED FULLY ACROSS THE SI JOINT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE ADVANCED THE INFERIOR POSITIONED IMPLANT FURTHER ACROSS THE SI JOINT AND ADDED BONE GRAFT TO THE SI JOINT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. NO NEW HARDWARE WAS ADDED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.