IFUSE IMPLANT SYSTEM
Received Sep 10, 2021 · Event occurred Aug 11, 2021
Report 3007700286-2021-00090 · MDR key 12457231
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
67 YR
- Arthralgia
- Arthralgia
Narrative
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU, CERTIFICATES OF CONFORMANCE AND FMEA, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem
THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR APPROXIMATELY 18 MONTHS BEFORE COMPLAINING OF A RECURRENCE OF SI JOINT PAIN SYMPTOMS. THE SURGEON THOUGHT THE MIDDLE IMPLANT MAY HAVE BEEN LOOSE EVEN THOUGH NO LUCENCY WAS SEEN ON IMAGING. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE MIDDLE POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE AND NOT LOOSE. THE IMPLANT HAD GOOD BONE IN/ON-GROWTH. THE EXPLANT VOID WAS NOT FILLED WITH BONE GRAFT, NOR WAS ANY ADDITIONAL HARDWARE ADDED. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.