IFUSE IMPLANT SYSTEM
Received Jun 2, 2021 · Event occurred May 4, 2021
Report 3007700286-2021-00055 · MDR key 11925897
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
33 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. IT WAS THE SURGEON'S DECISION TO REMOVE THE IMPLANT AT THE PATIENT'S REQUEST.
Description of Event or Problem
THE PATIENT HAD TRAUMA FROM A MOTOR VEHICLE ACCIDENT. IN (B)(6) 2020, THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS DURING A TRAUMA PROCEDURE WHERE ONE IMPLANT WAS INSTALLED ACROSS THE SI JOINT. THE PATIENT LATER COMPLAINED ABOUT LOW BACK PAIN. THE SURGEON DID NOT INDICATE THAT THE IMPLANT WAS MALPOSITIONED OR LOOSE. THERE WAS NO NERVE IMPINGEMENT. THE SURGEON DECIDED THAT THE BEST COURSE OF ACTION WAS TO REMOVE THE IMPLANT AT THE PATIENT'S REQUEST. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE IMPLANT USING CHISELS AS THE IMPLANT WAS SOLIDLY FIXED IN BONE. NO BONE GRAFT OR NEW HARDWARE WAS ADDED TO THE SI JOINT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.