IFUSE IMPLANT SYSTEM
Received Nov 30, 2021 · Event occurred Nov 2, 2021
Report 3007700286-2021-00127 · MDR key 12894247
Device
Product problems
- Inadequacy of Device Shape and/or Size
- Loss of Osseointegration
- Inadequacy of Device Shape and/or Size
- Loss of Osseointegration
Patient
44 YR · Female
- 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 PSEUDARTHROSIS OF SI JOINT.
Description of Event or Problem
THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN 2019 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED TO A DIFFERENT SURGEON WITH COMPLAINTS OF CONTINUED SI JOINT PAIN. THE SURGEON DETERMINED PSEUDARTHROSIS OF THE LEFT SI JOINT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED BOTH LEFT SIDE IMPLANTS AND REPLACED THEM WITH LARGER IMPLANTS OF THE SAME TYPE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.