TILINK-P SI JOINT FUSION SYSTEM
Received Sep 30, 2024 · Event occurred Aug 24, 2024
Report 3012495575-2024-00002 · MDR key 20333199
Device
Generic name
Sacroiliac Joint Fixation
Manufacturer
Surgentec, LlcCatalog number
SI-SGT-25
Lot number
A003
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- Wound Infection
- Wound Infection
Narrative
Description of Event or Problem
PATIENT HAD A POSTERIOR TILINK CASE PERFORMED WITH THE 25MM SCREW AND 5CC OSTEOFLO NANOPUTTY INSERTED ON (B)(6) 2024. THE PATIENT THEN DEVELOPED AN INFECTION AFTER THE SURGERY WAS PERFORMED, TIME OF INFECTION NOT DEFINED. AN EXPLANT OF THE IMPLANTED DEVICE IS SCHEDULED TO TAKE PLACE ON (B)(6) OR (B)(6) 2024.. THERE WAS NO REPORT OF A DEVICE OR ITS RELATED COMPONENTS MALFUNCTION OR FAILURE. IT WAS REPORTED BY TJ SURGEON THAT DUE TO PATIENT NON COMPLIANCE POST SURGERY (REMOVED THE STERI STRIPS AFTER TWO (2) DAYS POST SURGERY) THE INFECTION RESULTED.