IFUSE IMPLANT SYSTEM
Received Dec 29, 2021 · Event occurred Dec 3, 2021
Report 3007700286-2021-00142 · MDR key 13112754
Device
Product problems
- Malposition of Device
- Malposition of Device
Patient
85 YR · Male
- Undesired Nerve Stimulation
- Arthralgia
- Undesired Nerve Stimulation
- 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 PSEUDARTHROSIS AND POSSIBLE IMPLANT MALPOSITIONING DUE TO THE PATIENT'S ANOMALOUS ALA. 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
THE PATIENT HAS ANOMALOUS PELVIS ANATOMY. THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS ON (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF RADICULAR PAIN AFTER THE INITIAL PROCEDURE. THE SURGEON DETERMINED PSEUDARTHROSIS OF THE JOINT WITH AN ANOMALOUS ALA. ON (B)(6) 2021, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT. NO NEW HARDWARE WAS ADDED. NONE OF THE OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.
Description of Event or Problem
THE PATIENT HAS ANOMALOUS PELVIS ANATOMY. THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS ON (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF RADICULAR PAIN AFTER THE INITIAL PROCEDURE. THE SURGEON DETERMINED PSEUDARTHROSIS OF THE JOINT WITH AN ANOMALOUS ALA. ON (B)(6) 2021, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT. NO NEW HARDWARE WAS ADDED. NONE OF THE OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.
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 PSEUDARTHROSIS AND POSSIBLE IMPLANT MALPOSITIONING DUE TO THE PATIENT'S ANOMALOUS ALA. 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."