BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXLOCK

    MDR report key: 658250 · Received November 22, 2005

    Report

    Report Number
    3005039508-2005-00007
    Event Type
    Injury
    Date Received
    November 22, 2005
    Date of Event
    October 28, 2005
    Report Date
    October 28, 2005
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SCREW DRIVER TIP BROKE DURING USE. THIS CAUSED THE SURGEON TO REMOVE THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXLOCK ORTHOPEDIC SCREW DRIVER HXX ORTHOHELIX SURGICAL DESIGNS, INC. * 11298

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention