IFUSE IMPLANT SYSTEM
Received Dec 15, 2021 · Event occurred Nov 15, 2021
Report 3007700286-2021-00136 · MDR key 13011693
Device
Product problems
- Inadequacy of Device Shape and/or Size
- Loss of Osseointegration
- Inadequacy of Device Shape and/or Size
- Loss of Osseointegration
Patient
47 YR · Female
- Arthralgia
- Arthralgia
Narrative
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, CERTIFICATES OF ANALYSIS, 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 PSEUDARTHROSIS OF SI JOINT AND LATE IMPLANT LOOSENING.
Description of Event or Problem
THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN 2015 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED TO A DIFFERENT SURGEON WITH COMPLAINTS OF INTERMITTENT RADICULAR PAIN. THE SURGEON DETERMINED PSEUDARTHROSIS OF THE LEFT SI JOINT AND LOOSENING OF THE CAUDAL POSITIONED IMPLANT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CAUDAL POSITIONED IMPLANT USING CHISELS. NO BONE GRAFT OR HARDWARE WAS ADDED TO THE EXPLANT VOID. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.