IFUSE TORQ IMPLANT SYSTEM
Received Apr 3, 2024 · Event occurred Mar 8, 2024
Report 3007700286-2024-00001 · MDR key 19038073
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
72 YR · Male
- Pseudoaneurysm
- Pseudoaneurysm
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 BLEEDING IS THE SURGICAL PROCEDURE. A PSEUDOANEURYSM OF THE BRANCH OF THE SGA ON THE LATERAL ILIUM WAS IDENTIFIED AND A COIL WAS PLACED.
Description of Event or Problem
THE PATIENT UNDERWENT SI JOINT ARTHRODESIS IN (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED BRISK BLEEDING, WHICH WAS SUCCESSFULLY MANAGED WITH ELECTROCAUTERY. THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT INCIDENT. THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION AND REMAINED HEMODYNAMICALLY STABLE DURING AND AFTER THE PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. INTERVENTIONAL RADIOLOGY WAS CONSULTED. ARTERIOGRAPHY SHOWED NO ONGOING BLEEDING. A PSEUDOANEURYSM OF A SMALL ARTERIAL BRANCH OF THE LATERAL VASCULATURE WAS IDENTIFIED. THE INTERVENTIONAL RADIOLOGIST ELECTED TO PLACE A SMALL COIL TO ELIMINATE POTENTIAL RISK OF FUTURE BLEEDING. THE PATIENT DID NOT DEVELOP A HEMATOMA. THE PATIENT REMAINED HEMODYNAMICALLY STABLE OVERNIGHT AND WAS DISCHARGED IN THE MORNING.