BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC IMPLANT

    MDR report key: 3726490 · Received March 14, 2014

    Report

    Report Number
    3726490
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 14, 2014
    Manufacturer
    MEDARTIS
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    DISTAL SCREWS DID NOT LOCK TO THE PLATE. REQUIRED ALL TO BE REMOVED. A SYNTHES MODULAR MIN FRAGMENT (INS 0008840) HAD TO BE CALLED FOR AND THE PROCEDURE BEGUN AGAIN. THIS ADDED 30 MINUTES TO THE PROCEDURE. INCREASED SURGICAL AND TOURNIQUET TIME. EXCHANGED TO A NEW SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152199 ORTHOPEDIC IMPLANT ORTHOPEDIC IMPLANT HWC MEDARTIS 4655.10 CE1275

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR