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: INSTALLING 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

IN (B)(6) 2021, THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF RADICULAR PAIN SYMPTOMS FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED AND INSTALLED A 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.