BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVOL

    MDR report key: 1003956 · Received February 25, 2008

    Report

    Report Number
    MW5005686
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 25, 2008
    Manufacturer
    DAVOL FIELD ASSURANCE
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER THE SALUTE II FIXATION SYSTEM WAS TAKEN OUT OF THE PACKAGE, A SCREW FELL OUT. ANOTHER SALUTE II WAS TAKEN OUT OF THE PACKAGE, WHEN THE SAME THING OCCURRED. THE PT WAS NOT IN THE SURGICAL SUITE AT THE TIME THIS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVOL FIXATOR GDW DAVOL FIELD ASSURANCE

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Disability