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 DEVICES WERE OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS THE PATIENT'S FALL AND DYSMORPHIC ANATOMY. 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) 2021, THE PATIENT HAD LEFT SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER COMPLAINED OF PAIN AFTER A FALL. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS NOT FULLY IN BONE ACROSS THE SI JOINT. THERE WAS A LARGE GAP IN THE SI JOINT DUE TO THE PATIENT'S DYSMORPHIC ANATOMY. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. HE THEN INSTALLED A NEW IMPLANT OF THE SAME TYPE ANTERIORLY BETWEEN THE MIDDLE AND INFERIOR POSITIONED IMPLANTS. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.