BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VHS SCREWDRIVER

    MDR report key: 930653 · Received October 17, 2007

    Report

    Report Number
    2242816-2007-00047
    Event Type
    Malfunction
    Date Received
    October 17, 2007
    Date of Event
    September 7, 2007
    Report Date
    October 1, 2007
    Manufacturer
    EBI
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER PRE-DRILLING WITH A 2.5MM DRILL BIT, THE TIP OF A 2.5MM HEX SCREWDRIVER SLIPPED WHILE ATTEMPTING TO MANUALLY SCREW THE LAST 3 OUT OF 4, 3.5MM BONE SCREWS. ANOTHER 2.5 HEX SCREWDRIVER WAS USED FOR FINAL SCREW PLACEMENT. PLACEMENT OUTCOME: ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VHS SCREWDRIVER HXX EBI 012854

    Patients

    Seq Age Sex Outcome Treatment
    1 YR