BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXLOCK EXTREME

    MDR report key: 2170678 · Received July 12, 2011

    Report

    Report Number
    3005039508-2011-00010
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS
    Product Code
    HRS
    PMA / PMN Number
    K073624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE SALES REP REPORTED A BROKEN MTP PLATE THAT WAS IMPLANTED IN (B)(6) 2010 AND WAS POSSIBLY A NON/ MALUNION. DIABETIC NEUROPATHIC PATIENT. THE SURGEON REPORTED THAT THE PATIENT RETURNED FOR SURGICAL REMOVAL OF THE BROKEN HARDWARE AFTER THE PATIENT FELL IN THE SHOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXLOCK EXTREME BONE FIXATION PLATES AND SCREWS HRS ORTHOHELIX SURGICAL DESIGNS MTP-002-SL 3D781

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention