IFUSE IMPLANT SYSTEM
Received Jun 29, 2021 · Event occurred May 31, 2021
Report 3007700286-2021-00067 · MDR key 12089757
Device
Product problems
- Loss of Osseointegration
- Loss of Osseointegration
Patient
60 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 FOR THE IMPLANT LOOSENING IS THE PATIENT'S FALL.
Description of Event or Problem
THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER COMPLAINED OF A RECURRENCE OF SI-JOINT PAIN SYMPTOMS AFTER A FALL. THE SURGEON THOUGHT THAT THE SUPERIOR POSITIONED IMPLANT WAS LOOSE. APPROXIMATELY 10 DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT AND ADDED A NEW IMPLANT OF THE SAME TYPE IN A MORE POSTERIOR POSITION. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS UNKNOWN.