SIROS
Received Sep 16, 2025 · Event occurred Aug 18, 2025
Report 3008455034-2025-00002 · MDR key 23068993
Device
Generic name
Dilator
Manufacturer
Genesys SpineModel number
GSI206-03Catalog number
GSI206-03
Lot number
AM20221103
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
87 YR · Male
- Hemorrhage/Blood Loss/Bleeding
- Perforation of Vessels
- Hemorrhage/Blood Loss/Bleeding
- Perforation of Vessels
Narrative
Additional Manufacturer Narrative
THE SURGICAL TECHNIQUE OUTLINES THE IMPLANTS BE DELIVERED THROUGH A DRILL GUIDE BUT THE SURGEON PLACED THE IMPLANTS THROUGH A DILATOR.
Description of Event or Problem
DURING A LATERAL SI FUSION PROCEDURE, THE WORKING CHANNEL BEGAN FILLING WITH BLOOD AFTER PLACEMENT OF THE SECOND SI SCREW. THE BLEED WAS DIFFICULT TO CONTROL AND THE PATIENT LOST APPROXIMATELY 750CC OF BLOOD. ONCE THE BLEED WAS CONTROLLED THE PATIENT WAS TRANSFERRED BY AMBULANCE TO A HOSPITAL. WHILE AT THE HOSPITAL, A NEUROSURGEON CONFIRMED THE SI SCREWS WERE PROPERLY PLACED. THE PATIENT WAS RELEASED THE NEXT DAY.