BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDYS-TLIF TIVAC

    MDR report key: 18332158 · Received December 14, 2023

    Report

    Report Number
    3009962553-2023-00005
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    December 5, 2023
    Report Date
    December 14, 2023
    Manufacturer
    CLARIANCE SAS
    Product Code
    OVD
    PMA / PMN Number
    K183259
    Product Problem
    Yes
    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 AS A MALFUNCTION. (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 AS A MALFUNCTION.

    Description of Event or Problem · 0

    SURGEON WAS ON THE PATIENTS LEFT AT L3-4 USING 7MM TI COATED PEEK BANANA CAGE (41532907-S) // (LOT = J4E8X-K406Y) WITH THE 15-DEGREE ANGLED INSERTER. NO SCREWS WERE PLACED YET. IMPLANT WAS IMPACTED INTO DISC SPACE AND ARTICULATED PROPERLY. THE WHEEL OF THE INSERTER WAS TURNED TO DISENGAGE THE IMPLANT FROM THE INSERTER AND A SLAP HAMMER WAS USED TO GET THE INSERTER OUT OF THE DISC SPACE. WHILE SLAP HAMMERING, THE PROXIMAL TANTALUM MARKER PORTION OF THE CAGE CAME OUT WITH THE INSERTER, STILL SLIGHTLY ENGAGED TO INSERTER. THE BROKEN PIECE WAS RETRIEVED AND REMOVED FROM THE FIELD. THE REST OF THE IMPLANT WAS PLACED PROPERLY IN THE DISC SPACE.

    Description of Event or Problem · 0

    SURGEON WAS ON THE PATIENTS LEFT AT L3-4 USING 7MM TI COATED PEEK BANANA CAGE (41532907-S) // (LOT = J4E8X-K406Y) WITH THE 15-DEGREE ANGLED INSERTER. NO SCREWS WERE PLACED YET. IMPLANT WAS IMPACTED INTO DISC SPACE AND ARTICULATED PROPERLY. THE WHEEL OF THE INSERTER WAS TURNED TO DISENGAGE THE IMPLANT FROM THE INSERTER AND A SLAP HAMMER WAS USED TO GET THE INSERTER OUT OF THE DISC SPACE. WHILE SLAP HAMMERING, THE PROXIMAL TANTALUM MARKER PORTION OF THE CAGE CAME OUT WITH THE INSERTER, STILL SLIGHTLY ENGAGED TO INSERTER. THE BROKEN PIECE WAS RETRIEVED AND REMOVED FROM THE FIELD. THE REST OF THE IMPLANT WAS PLACED PROPERLY IN THE DISC SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2276762 IDYS-TLIF TIVAC IDYS-TLIF TIVAC CAGE L29MM H07MM OVD CLARIANCE SAS J4E8X-K406Y

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown