BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VUELOCK SCREW INSERTER

    MDR report key: 1063845 · Received June 19, 2008

    Report

    Report Number
    2242816-2008-00093
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 11, 2008
    Manufacturer
    EBI, L.P.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL TIP OF THE INSERTER BROKE OFF IN THE SCREW HEAD. THE FRAGMENTED PIECE WAS RETRIEVED AND DISCARDED. PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VUELOCK SCREW INSERTER HXX EBI, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1