BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI MAXLOCK EXTREME

    MDR report key: 3034537 · Received April 1, 2013

    Report

    Report Number
    3005039508-2013-00005
    Event Type
    Injury
    Date Received
    April 1, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER REP - DURING SURGERY (2) MINI MAXLOCK EXTREME TAPERED DRIVERS TWISTED AND THE DRIVER TIPS SNAPPED OFF IN THE SCREW HEAD. THEY REMAIN IMPLANTED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131988 MINI MAXLOCK EXTREME MINI MAXLOCK EXTREME TAPERED DRIVER HWC ORTHOHELIX SURGICAL DESIGNS, INC. MXM-056T

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention