BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRE-SHAPED ACHILLES TENDON W/CALCANEUS

    MDR report key: 481579 · Received August 26, 2003

    Report

    Report Number
    MW1029408
    Event Type
    Malfunction
    Date Received
    August 26, 2003
    Date of Event
    August 14, 2003
    Report Date
    August 19, 2003
    Manufacturer
    REGENERATION TECHNOLOGIES, INC.
    Product Code
    LMO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON NOTED ALLOGRAFT AT ONE DISTAL END, WITH SOME FRAYED AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRE-SHAPED ACHILLES TENDON W/CALCANEUS * LMO REGENERATION TECHNOLOGIES, INC. * 101031698

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other