BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI MAXLOCK EXTREME

    MDR report key: 2919816 · Received January 14, 2013

    Report

    Report Number
    3005039508-2013-00001
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 14, 2013
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HWC
    PMA / PMN Number
    101962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DRIVER SNAPPED OFF AND REMAINS IN THE SCREW HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19668 MINI MAXLOCK EXTREME SCREW, FIXATION, BONE HWC ORTHOHELIX SURGICAL DESIGNS, INC. MXM-056T

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention