BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXLOCK EXTREME

    MDR report key: 3827631 · Received May 7, 2014

    Report

    Report Number
    3005039508-2014-00009
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    April 8, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HWC
    PMA / PMN Number
    K113048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RECEIVED A REPORT OF A PT WITH EIGHT BROKEN SCREWS SIX MONTHS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274893 MAXLOCK EXTREME BONE SCREWS HWC ORTHOHELIX SURGICAL DESIGNS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention