BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDYS-TLIF TIVAC

    MDR report key: 18525907 · Received January 17, 2024

    Report

    Report Number
    3008992889-2023-00001
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    December 19, 2023
    Report Date
    January 17, 2024
    Manufacturer
    CLARIANCE SAS
    Product Code
    OVD
    UDI-DI
    03700780628643
    PMA / PMN Number
    K183259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE USING A SLAP HAMMER TO GET THE INSERTER OUT OF THE DISC SPACE, THE PROXIMAL TANTALUM MARKER PORTION OF THE CAGE BROKE FROM THE REST OF THE CAGE. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PORTION AND REMOVE IT FROM THE DISC SPACE. THEN, THE SURGEON WAS ABLE TO POSITION THE REST OF THE CAGE PROPERLY IN THE DISC SPACE.THIS EVENT IS REPORTABLE.

    Description of Event or Problem · 0

    SURGEON WAS ON THE PATIENT'S RIGHT AT L2-3 USING 9MM TI COATED PEEL BANANA CAGE (REF= (B)(4)// LOT = N1A9X-N113Y). IMPLANT WAS IMPACTED INTO DISC SPACE AND ARTICULATED PROPERLY. THE WHEEL OF THE INSERTER WAS TURNED TO DISENGAGE THE IMPLANT AND A SLAP HAMMER WAS USED TO GET INSERTER OUT OF DISC SPACE. THE PROXIMAL TANTALUM MARKER PORTION OF THE IMPLANT BROKE FROM THE REST OF THE IMPLANT DURING THIS. THE BROKEN PIECE WAS RETRIEVED AND REMOVED FROM THE FIELD. THERE WAS NO HARM TO THE PATIENT AND NO DELAY TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1774402 IDYS-TLIF TIVAC IDYS-TLIF CAGE TIVAC 30X35 - H16MM - 14 OVD CLARIANCE SAS N1A9X-N113Y 03700780628643

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown