InjuryOUR
TILINK - P
Received Aug 5, 2024
Report 3012495575-2024-00001 · MDR key 19904412
Device
Generic name
Tilink - P
Manufacturer
Surgentec, LlcModel number
TILINK-P 12X25MM SCREWCatalog number
SI-SGT-25
Lot number
A002
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, SCREW ANCHOR 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 TOOK PLACE ON (B)(6) 2024. THERE WAS NO REPORT OF A DEVICE OR ITS RELATED COMPONENTS MALFUNCTION OR FAILURE. IT WAS REPORTED THE SURGEON THAT THERE WAS POTENTIAL SANITARY ISSUES WITH PATIENT.