IFUSE IMPLANT SYSTEM
Received Jul 14, 2021 · Event occurred Jun 24, 2021
Report 3007700286-2021-00074 · MDR key 12166641
Device
Product problems
- Loss of Osseointegration
- Loss of Osseointegration
Patient
41 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 IS IMPLANT LATE LOOSENING.
Description of Event or Problem
THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR APPROXIMATELY FOUR MONTHS BEFORE COMPLAINING OF A RECURRENCE OF SI JOINT PAIN SYMPTOMS. THE PATIENT COMPLAINED OF LOCAL PAIN AT THE CAUDAL IMPLANT SITE. THE SURGEON THOUGHT THE CAUDAL IMPLANT WAS SLIGHTLY LOOSE BUT DID NOT SEE ANY HALOS OR LUCENCY AROUND THE CAUDAL IMPLANT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CAUDAL POSITIONED IMPLANT AND FILLED THE EXPLANT VOID WITH BONE GRAFT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS UNKNOWN.