IFUSE IMPLANT SYSTEM

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU 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 AN INITIAL IMPLANT AND POSSIBLE IMPLANT LATE LOOSENING. 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 RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD THREE YEARS OF PAIN RELIEF BEFORE COMPLAINING OF A RECURRENCE OF SI JOINT PAIN. THE SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT WAS MALPOSITIONED TOO VENTRALLY AND POSSIBLE LOOSENING OF THE MIDDLE AND CAUDAL IMPLANTS ON THE SACRAL SIDE. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE HE REMOVED THE CRANIAL POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. HE THEN ADDED TWO ADDITIONAL IMPLANTS OF THE SAME TYPE IN MORE CRANIAL AND CAUDAL POSITIONS. THE PATIENT NOW HAS FOUR IMPLANTS IN THEIR RIGHT SI JOINT. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.