BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARCO(R) LOCKING SCREW

    MDR report key: 3051309 · Received April 10, 2013

    Report

    Report Number
    1043534-2013-00629
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    February 28, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A REPORTABLE MALFUNCTION. 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 SCREW HEAD BROKE WHILE SCREWING INTO PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149064 DARCO(R) LOCKING SCREW SMALL JOINT COMPONENT, CODE:HWC HWC WRIGHT MEDICAL TECHNOLOGY, INC 058602449

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female