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: USING TOO LONG OF AN IMPLANT. 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

THE PATIENT HAD STAGED BILATERAL SI JOINT ARTHRODESIS WITH THE RIGHT SIDE BEING PERFORMED IN (B)(6) 2018 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED RIGHT SIDE RADICULAR PAIN. THE PATIENT WAS REFERRED TO A DIFFERENT SURGEON WHO DETERMINED THAT THE MIDDLE IMPLANT ON THE RIGHT SIDE HAD BREACHED THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE RIGHT SIDE MIDDLE IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. HE THEN INSTALLED A NEW, SHORTER IMPLANT OF THE SAME TYPE INTO THE EXPLANT VOID. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.