inforMED
InjuryOUR

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, Llc

Catalog 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.