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; MALPOSITIONING OF THE IMPLANT, USING TOO LONG OF AN IMPLANT OR INSTALLING THE IMPLANTS TOO DEEP. 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 SI JOINT ARTHRODESIS OVER FIVE YEARS AGO WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD PAIN RELIEF FOR MANY YEARS BEFORE REPORTING TO A DIFFERENT SURGEON WITH PAIN COMPLAINTS. THE SURGEON DETERMINED THAT ONE OF THE IMPLANTS WAS MALPOSITIONED AND HAD BREACHED THE NEUROFORAMEN AS WELL AS A POSSIBLE SACRAL FRACTURE. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE IMPLANT THAT HAD BREACHED THE NEUROFORAMEN USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.