BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIN PEAKS

    MDR report key: 13576118 · Received February 22, 2022

    Report

    Report Number
    3010758686-2022-00001
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Report Date
    February 22, 2022
    Manufacturer
    SPINEWAY SA
    Product Code
    LXH
    UDI-DI
    03663422600387
    PMA / PMN Number
    K152355
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A NEW VERSION OF THE CAGE HOLDER 026HLC1 WAS RELEASED BEFORE THE NEW VERSIONS THE ASSOCIATED IMPACTORS 318HLP1 AND 378HLS1 WERE RELEASED. THE DESIGNS OF THE NEW CAGE HOLDER 026HLC1 IS NOT COMPATIBLE WITH THE PREVIOUS DESIGN OF THE IMPACTORS. IF THIS INSTRUMENT HAS REACHED THE SURGERY ROOM, IT WOULD HAVE NOT BEEN POSSIBLE TO IMPLANT THE LUMBAR CAGE. IN THAT CASE, AN INTERVENTION WOULD HAVE BEEN REQUIRED TO PREVENT PERMANENT DAMAGE (ABSENCE OF DISC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2444188 TWIN PEAKS HOLDER FOR LUMBAR CAGE LXH SPINEWAY SA 026HLC1 4210074 03663422600387

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention