IFUSE IMPLANT SYSTEM
Received Nov 11, 2021 · Event occurred Oct 18, 2021
Report 3007700286-2021-00111 · MDR key 12800516
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
41 YR · Female
- Arthralgia
- Arthralgia
Narrative
Description of Event or Problem
THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR APPROXIMATELY SIX MONTHS BEFORE COMPLAINING OF A RECURRENCE OF SI JOINT PAIN SYMPTOMS. THE SURGEON DID NOT DETERMINE THAT ANY OF THE IMPLANTS WERE LOOSE OR MALPOSITIONED BUT DECIDED TO REMOVE CAUSAL POSITIONED IMPLANT REGARDLESS. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CAUDAL POSITIONED IMPLANT. 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.
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.