MalfunctionOUR
TILINK-P SI JOINT FUSION SYSTEM
Received Sep 30, 2024 · Event occurred Sep 25, 2024
Report 3012495575-2024-00003 · MDR key 20333376
Device
Generic name
Sacroiliac Joint Fixation
Manufacturer
Surgentec, LlcModel number
NACatalog number
SI-A-01
Lot number
A004
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NA.
Description of Event or Problem
THE SURGEON WAS PERFORMING A TILINK-P (POSTERIOR) 25MM PROCEDURE AND AFTER THE SCREW WAS IMPLANTED, THEY NOTICED IN THE OUTER OBLIQUE X-RAY THAT THE ANCHOR WAS SPLAYED OUTWARD. FROM THE IMAGES, THEY ARE UNABLE TO IDENTIFY AND CONFIRM IF THE ANCHOR IS BENT OR BROKEN. HOWEVER THE SURGERY WAS SUCESSFULLY COMPLETED.