BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIREBIRD SFS

    MDR report key: 6545853 · Received May 4, 2017

    Report

    Report Number
    2183449-2017-00014
    Event Type
    Malfunction
    Date Received
    May 4, 2017
    Date of Event
    April 4, 2017
    Report Date
    May 1, 2017
    Manufacturer
    ORTHOFIX INC.
    Product Code
    LXH
    UDI-DI
    18257200045600
    PMA / PMN Number
    K994217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THAT THE SCREW BROKE OFF OF THE ROD GRIPPER DURING THE CASE. NO ADVERSE EFFECTS TO THE PATIENT. NO DELAY IN THE DURATION OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324833 FIREBIRD SFS ROD GRIPPER LXH ORTHOFIX INC. 51-1480 30256-MF30 18257200045600

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR