IFUSE IMPLANT SYSTEM
Received Jan 24, 2022 · Event occurred Dec 29, 2021
Report 3007700286-2021-00149 · MDR key 13335097
Device
Product problems
- Loss of Osseointegration
- Loss of Osseointegration
Patient
71 YR · Female
- Arthralgia
- Arthralgia
Narrative
Description of Event or Problem
THE PATIENT IS OSTEOPOROTIC. THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER COMPLAINED OF A RECURRENCE OF SI-JOINT PAIN SYMPTOMS. THE SURGEON THOUGHT THAT THE INFERIOR POSITIONED IMPLANT MAY HAVE BEEN LOOSE. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT AND ADDED A NEW IMPLANT OF A DIFFERENT TYPE IN A MORE ANTERIOR POSITION FROM THE INITIAL IMPLANT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS UNKNOWN.
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 IMPLANT LATE LOOSENING. THE PATIENT'S CONDITION, OSTEOPOROSIS, MAY HAVE CONTRIBUTED TO THE PERCEIVED LOOSENING.