IFUSE IMPLANT SYSTEM
Received May 11, 2021 · Event occurred Apr 13, 2021
Report 3007700286-2021-00043 · MDR key 11809689
Device
Product problems
- Inadequacy of Device Shape and/or Size
- Loss of Osseointegration
- Inadequacy of Device Shape and/or Size
- Loss of Osseointegration
Patient
63 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 IMPROPER IMPLANT SIZE SELECTION, USING AN IMPLANT THAT WAS TOO SHORT.
Description of Event or Problem
THE PATIENT HAD LEFT SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR SIX MONTHS BEFORE COMPLAINING OF A RECURRENCE OF SI-JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED LOOSENING OF THE MIDDLE POSITIONED IMPLANT WHICH MAY HAVE BEEN TOO SHORT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE MIDDLE POSITIONED IMPLANT AND REPLACED IT WITH A LONGER IMPLANT OF THE SAME TYPE. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.