BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI MAXLOCK EXTREME

    MDR report key: 2994372 · Received March 5, 2013

    Report

    Report Number
    3005039508-2013-00003
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    December 15, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT - WE CONFIRMED THE DRIVER TIP WAS BROKEN PER THE FIELD REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE REP - 2.4MM HEX STAR SCREW DRIVER BROKE OFF INTO THE PLATE. IT COULD NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94328 MINI MAXLOCK EXTREME MINI MAXLOCK EXTREME DRIVER LXH ORTHOHELIX SURGICAL DESIGNS, INC. MXM-056 1818011

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention