GOLDEN ISLES PEDICLE SCREW SYSTEM
Received May 13, 2025 · Event occurred Apr 25, 2025
Report 3019356409-2025-00001 · MDR key 22009694
Device
Generic name
Thoracolumbosacral Pedicle Screw System
Manufacturer
Intelivation Technologies, LlcModel number
C51-0000-A00 / C51-1000-A03Catalog number
N/A
Lot number
SEE UDI SECTION
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
63 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
FOLLOWED UP WITH DOCTOR REGARDING THE PATIENT STATE. HE STATED THAT THE PATIENT IS DOING WELL AND HE DOESN'T THINK THAT THE EVENT WILL AFFECT HER IN ANY WAY. HE ALSO STATED THAT THE ERROR WAS HIS BECAUSE HIS TECHNIQUE IS A LITTLE DIFFERENT FROM WHAT'S DESCRIBED IN THE IFU.
Additional Manufacturer Narrative
INVESTIGATION TEAM FOLLOWED UP WITH DOCTOR ON (B)(6) 2025. DR STATED THAT THE DETACHMENT IS DUE TO HIS TECHNIQUE AND WILL NOT CONDUCT ANY CORRECTION AS PATIENT IS HEALING WELL DESPITE THE DETACHMENT.
Description of Event or Problem
POST OPERATIVE X-RAY SHOWED THAT THE TWO SUPERIOR SET SCREWS WERE DISENGAGED FROM THE TULIPS HEADS.
Remedial action
- Patient Monitoring