BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARCO(R) BOW II PLATE

    MDR report key: 2905617 · Received January 9, 2013

    Report

    Report Number
    1043534-2013-00035
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    September 12, 2012
    Report Date
    April 19, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    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 IS THE SAME EVENT AS 1043534-2013-00036.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO BROKEN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11593 DARCO(R) BOW II PLATE SMALL JOINT COMPONENT, CODE:HRS HRS WRIGHT MEDICAL TECHNOLOGY, INC 1044435

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention