BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TILINK-P SI JOINT FUSION SYSTEM

    MDR report key: 20333376 · Received September 30, 2024

    Report

    Report Number
    3012495575-2024-00003
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 25, 2024
    Manufacturer
    SURGENTEC, LLC
    Product Code
    OUR
    PMA / PMN Number
    K230857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NA.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2602687 TILINK-P SI JOINT FUSION SYSTEM SACROILIAC JOINT FIXATION OUR SURGENTEC, LLC NA A004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown