BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXLOCK

    MDR report key: 759501 · Received October 24, 2005

    Report

    Report Number
    3005039508-2005-00002
    Event Type
    Malfunction
    Date Received
    October 24, 2005
    Date of Event
    September 1, 2005
    Report Date
    September 1, 2005
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REVIEWING THE BREAKAGE, IT APPEARS THAT THE SURGEON APPLIED AN EXCESSIVE SIDE LOAD WHICH RESULTED IN THE TIP BREAKAGE.

    Description of Event or Problem · 1

    SCREW DRIVER PILOT TIP BROKE DURING USE, INSIDE SCREW HEAD. SURGEON DID NOT REMOVE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXLOCK ORTHOPEDIC SCREWDRIVER HXX ORTHOHELIX SURGICAL DESIGNS, INC. NA 12298

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN