BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TILINK-P SI JOINT FUSION SYSTEM

    MDR report key: 20333199 · Received September 30, 2024

    Report

    Report Number
    3012495575-2024-00002
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    August 24, 2024
    Report Date
    September 25, 2024
    Manufacturer
    SURGENTEC, LLC
    Product Code
    OUR
    PMA / PMN Number
    K230857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2587968 TILINK-P SI JOINT FUSION SYSTEM SACROILIAC JOINT FIXATION OUR SURGENTEC, LLC A003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention