IFUSE IMPLANT SYSTEM
Received May 13, 2021 · Event occurred Apr 14, 2021
Report 3007700286-2021-00044 · MDR key 11823487
Device
Product problems
- Inadequacy of Device Shape and/or Size
- Loss of Osseointegration
- Inadequacy of Device Shape and/or Size
- Loss of Osseointegration
Patient
61 YR
- Arthralgia
- Arthralgia
Narrative
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 IMPLANT LATE LOOSENING POSSIBLY DUE TO THE PATIENT'S OSTEOPOROTIC CONDITION.
Description of Event or Problem
THE PATIENT IS A (B)(6) FEMALE WITH OSTEOPOROSIS WHO HAD BILATERAL SI JOINT ARTHRODESIS APPROXIMATELY FIVE YEARS AGO (2016). THREE IMPLANTS WERE INSTALLED ON EACH SIDE. THE PATIENT HAD SI JOINT PAIN RELIEF FOR APPROXIMATELY FIVE YEARS BEFORE COMPLAINING OF A RECURRENCE OF RIGHT SIDE SI JOINT PAIN SYMPTOMS AFTER OSTEOPATHIC TREATMENT FOR OTHER DISORDERS. THE SURGEON DETERMINED LOOSENING OF THE RIGHT SIDE MIDDLE POSITIONED IMPLANT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE FIRST REMOVED THE RIGHT SIDE MIDDLE POSITIONED IMPLANT USING CHISELS. HE THEN INSTALLED A LONGER IMPLANT OF THE SAME TYPE INTO THE EXPLANT VOID. FINALLY, HE INSTALLED AN ADDITIONAL IMPLANT OF THE SAME TYPE BETWEEN THE MIDDLE AND CAUDAL POSITIONED IMPLANTS TO HELP STABILIZE THE JOINT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT NOW HAS FOUR IMPLANTS IN HER RIGHT SI JOINT. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.