IFUSE IMPLANT SYSTEM
Received May 3, 2021 · Event occurred Apr 5, 2021
Report 3007700286-2021-00038 · MDR key 11767275
Device
Product problems
- Malposition of Device
- Malposition of Device
Patient
59 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 DEVICES WERE OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS USER ERROR: IMPLANT MALPOSITIONING. ADDITIONALLY, PER THE SURGICAL TECHNIQUE MANUAL, THE SURGEON IS INSTRUCTED AS FOLLOWS: "PRIOR TO CLOSURE, ALWAYS OBTAIN FINAL FLUOROSCOPIC IMAGES IN THE LATERAL, INLET, AND OUTLET VIEWS TO CONFIRM NO CORTICAL WALL BREACH, FORAMEN BREACH, OR OTHER MALPOSITION."
Description of Event or Problem
IN (B)(6) 2021, THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN CONJUNCTION WITH A LONG SPINAL CONSTRUCT PROCEDURE. ONE IMPLANT WAS INSTALLED ON EACH SIDE. THE POST-OP CT SCAN INDICATED THAT THE LEFT SIDE IMPLANT WAS MALPOSITIONED TOO VENTRALLY. THE PATIENT WAS ASYMPTOMATIC AND DID NOT REPORT ANY PAIN SYMPTOMS. ONE WEEK AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE LEFT SIDE IMPLANT. THE RIGHT SIDE IMPLANT WAS NOT ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.