IFUSE IMPLANT SYSTEM
Received Nov 17, 2022 · Event occurred Oct 15, 2022
Report 3007700286-2022-00008 · MDR key 15815604
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
75 YR · Male
- Pseudoaneurysm
- Pseudoaneurysm
Narrative
Description of Event or Problem
THE PATIENT HAD SI JOINT ARTHRODESIS IN (B)(6) 2022 WHERE THREE IMPLANTS WERE INSTALLED. FIVE DAYS AFTER THE PATIENT'S PROCEDURE THEY WENT TO THE HOSPITAL DUE TO PAIN AND BRUISING. AFTER EVALUATION AND A WORK-UP BY INTERVENTIONAL RADIOLOGY IT WAS DETERMINED THAT THERE WAS A PSEUDO-ANEURYSM OF ONE OF THE BRANCHES OF THE SUPERIOR GLUTEAL ARTERY. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT ENDOVASCULAR COILING OF THE ARTERY.
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 THE SURGICAL PROCEDURE. THE SURGEON DETERMINED PSEUDO-ANEURYSM.