BEUDAMED
    FDA Adverse Event Summary report: N

    MINI MAXLOCK EXTREME

    MDR report key: 3993445 · Received July 25, 2014

    Report

    Report Number
    3005039508-2014-00010
    Date Received
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HRS
    PMA / PMN Number
    K101962
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    MINI MAXLOCK EXTREME 6-HOLE ORTHOLINK (MXM-002-6P) BROKE 6 WEEKS POST-OP. PT WAS PUT IN A FRACTURE BOOT POST-OP. PT WAS NOT SUPPOSED TO BE WALKING ON IT, BUT DID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436791 MINI MAXLOCK EXTREME NONE HRS ORTHOHELIX SURGICAL DESIGNS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1