BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARCO(R) CPS CALCANEAL PLATE

    MDR report key: 3501925 · Received December 5, 2013

    Report

    Report Number
    1043534-2013-01967
    Event Type
    Malfunction
    Date Received
    December 5, 2013
    Date of Event
    October 7, 2013
    Report Date
    October 31, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY AFTER 10 MONTHS, THE PATIENT HAD PAIN. SO THE SURGEON FOUND THE BREAKAGE OF THE PLATE BY X-RAY. THE SURGEON HAD CONFIRMED THE NON-UNION AT (B)(6), 2013 BY X-RAY. BUT THE SURGEON COULDN'T FIND THE BREAKAGE OF THE PLATE AT THAT TIME. MED ACTIVITY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630844 DARCO(R) CPS CALCANEAL PLATE SMALL JOINT COMPONENT, CODE:HWC HWC WRIGHT MEDICAL TECHNOLOGY, INC. 08948221301

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR