BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDYS-TLIF TIVAC

    MDR report key: 17746225 · Received September 14, 2023

    Report

    Report Number
    3009962553-2023-00003
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    August 15, 2023
    Report Date
    September 13, 2023
    Manufacturer
    CLARIANCE SAS
    Product Code
    OVD
    UDI-DI
    03700780628643
    PMA / PMN Number
    K183259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE IMPACTING THE TLIF CAGE INTO THE DISC SPACE, BEFORE ARTICULATING THE INSERTER, 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 ACCORDINGLY. THIS EVENT IS REPORTABLE AS A MALFUNCTION.

    Additional Manufacturer Narrative · 0

    WHILE IMPACTING THE TLIF CAGE INTO THE DISC SPACE, BEFORE ARTICULATING THE INSERTER, 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 ACCORDINGLY. THIS EVENT IS REPORTABLE AS A MALFUNCTION. ON 11/28/2023, THIS MEDWATCH 3500A FILING NOW INCLUDES THE ANALYSIS REPORT FROM THE MANUFACTURER.

    Description of Event or Problem · 0

    THE SURGEON WAS ON THE PATIENT'S RIGHT AT L4-5 USING A 9MM TI COATED PEEK BANANA CAGE WITH THE 25-DEGREE ANGLED INSERTER. WHILE IMPACTING INTO THE DISC SPACE, BEFORE ARTICULATING THE INSERTER, THE PROXIMAL TANTALUM MARKER PORTION OF THE CAGE BROKE FROM THE REST OF THE CAGE. HE WAS ABLE TO RETRIEVE THE BROKEN PORTION AND REMOVE IT FROM THE DISC SPACE. HE THEN USED A TAMP/PUSHER TO POSITION THE REST OF THE CAGE ACCORDINGLY. THERE WAS NOT A SIGNIFICANT DELAY TO THE CASE, OR ANY HARM DONE TO THE PATIENT BECAUSE OF THE INCIDENT. ALL THE BROKEN PIECES OF THE IMPLANT WERE REMOVED FROM THE PATIENT AND DISCARDED BY THE SURGICAL STAFF AND CAN'T BE SENT BACK FOR ANALYSIS.

    Description of Event or Problem · 0

    THE SURGEON WAS ON THE PATIENT'S RIGHT AT L4-5 USING A 9MM TI COATED PEEK BANANA CAGE WITH THE 25-DEGREE ANGLED INSERTER. WHILE IMPACTING INTO THE DISC SPACE, BEFORE ARTICULATING THE INSERTER, THE PROXIMAL TANTALUM MARKER PORTION OF THE CAGE BROKE FROM THE REST OF THE CAGE. HE WAS ABLE TO RETRIEVE THE BROKEN PORTION AND REMOVE IT FROM THE DISC SPACE. HE THEN USED A TAMP/PUSHER TO POSITION THE REST OF THE CAGE ACCORDINGLY. THERE WAS NOT A SIGNIFICANT DELAY TO THE CASE, OR ANY HARM DONE TO THE PATIENT BECAUSE OF THE INCIDENT. ALL THE BROKEN PIECES OF THE IMPLANT WERE REMOVED FROM THE PATIENT AND DISCARDED BY THE SURGICAL STAFF AND CAN'T BE SENT BACK FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391039 IDYS-TLIF TIVAC IDYS TLIF TIVAC CAGE L29MM H09MM, OVD CLARIANCE SAS N1A9X-N113Y 03700780628643

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown