BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDYS-TLIF TIVAC

    MDR report key: 18480347 · Received January 9, 2024

    Report

    Report Number
    3009962553-2023-00006
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    December 19, 2023
    Report Date
    January 9, 2023
    Manufacturer
    CLARIANCE SAS
    Product Code
    OVD
    UDI-DI
    03700780628643
    PMA / PMN Number
    K183259
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. ON (B)(6) 2024, IT WOULD APPEAR THAT ANGULATION IS EXERTED WHEN THE PATIENT'S ANATOMY IS COMPLICATED AS WELL AS WHEN USING THE PRODUCT WITH A MINIMALLY INVASIVE TECHNIQUE. THIS BRINGS US TO THE LIMITS OF THE TLIF TIVAC SYSTEM. THIS PROCEDURE IS, HOWEVER, NOT DESCRIBED IN THE SURGICAL TECHNIQUE.

    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.

    Description of Event or Problem · 0

    SURGEON WAS ON THE PATIENT'S RIGHT AT L2-3 USING 9MM TI COATED PEEL BANANA CAGE (REF = 41532909-S // 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
    606222 IDYS-TLIF TIVAC IDYS-TLIF TIVAC CAGE L29MM H09MM OVD CLARIANCE SAS N1A9X-N113Y 03700780628643

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown