IFUSE IMPLANT SYSTEM
Received Dec 22, 2021 · Event occurred Nov 30, 2021
Report 3007700286-2021-00134 · MDR key 13064285
Device
Product problems
- Malposition of Device
- Malposition of Device
Patient
62 YR · Female
- 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: NOT INSTALLING THE IMPLANTS FULLY ACROSS THE SI JOINT. 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 HAD LEFT SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE MIDDLE AND INFERIOR POSITIONED IMPLANTS WERE NOT POSITIONED FULLY ACROSS THE SI JOINT. TWO WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANTS AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. HE ALSO IMPACTED THE SECOND IMPLANT FURTHER ACROSS JOINT. THE PREEXISTING SUPERIOR POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS WERE REDUCED FOLLOWING THE REVISION PROCEDURE.
Description of Event or Problem
THE PATIENT HAD LEFT SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE MIDDLE AND INFERIOR POSITIONED IMPLANTS WERE NOT POSITIONED FULLY ACROSS THE SI JOINT. TWO WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANTS AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. HE ALSO IMPACTED THE SECOND IMPLANT FURTHER ACROSS JOINT. THE PREEXISTING SUPERIOR POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS WERE REDUCED 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 DEVICES WERE OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS USER ERROR: NOT INSTALLING THE IMPLANTS FULLY ACROSS THE SI JOINT. 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."