IFUSE IMPLANT SYSTEM
Received Apr 21, 2021 · Event occurred Mar 30, 2021
Report 3007700286-2021-00034 · MDR key 11701733
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
52 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 PATIENT'S PAIN SYMPTOMS COULD NOT BE DETERMINED. IT IS UNLIKELY TO BE RELATED TO THE SI JOINT IMPLANTS.
Description of Event or Problem
IN (B)(6) 2021, THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT REPORTED LEFT THIGH PAIN FOLLOWING THE INITIAL PROCEDURE. IMAGING AND NEUROMONITORING DID NOT SHOW THAT ANY OF THE IMPLANTS WERE MALPOSITIONED OR IMPINGING ON THE NEUROFORAMEN, BUT THE SURGEON DECIDED TO REMOVE THE SUPERIOR POSITIONED IMPLANT TO RULE IT OUT AS THE CAUSE OF THE PAIN. APPROXIMATELY TWO WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. THE EXPLANT VOID WAS NOT FILLED WITH BONE GRAFT AND NO ADDITIONAL HARDWARE WAS ADDED. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS DID NOT RESOLVE FOLLOWING THE REVISION PROCEDURE. THE SURGEON WILL RECOMMEND THAT THE PATIENT'S SPINAL CORD STIMULATOR SETTINGS BE ADJUSTED.