BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIREBIRD SFS

    MDR report key: 6572119 · Received May 17, 2017

    Report

    Report Number
    2183449-2017-00015
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    May 2, 2017
    Manufacturer
    ORTHOFIX INC.
    Product Code
    LXH
    UDI-DI
    18257200046560
    PMA / PMN Number
    K081684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE TWO INSTRUMENTS INVOLVED IN THE CASE. 51-7111 HOOK PUSHER LOT 30629-MG01 MANUFACTURE DATE; 07/01/2010. 51-7111 HOOK PUSHER LOT 30629-MH06 MANUFACTURE DATE; 08/06/2010.

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THAT WHILE TRYING TO INSERT LUMBAR LAMINA HOOKS, SURGEON STATED HOOK KEPT FALLING OFF. UPON INSPECTION BOTH HOOK PUSHERS WERE FAILING TO CLOSE ALL THE WAY RESULTING IN A DELAY IN THE CASE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355393 FIREBIRD SFS HOOK PUSHER LXH ORTHOFIX INC. 51-7111 18257200046560

    Patients

    Seq Age Sex Outcome Treatment
    1