BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALOR(R) TARGETING GUIDE

    MDR report key: 2410795 · Received January 11, 2012

    Report

    Report Number
    1043534-2012-00026
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    December 5, 2011
    Report Date
    December 7, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HSB
    PMA / PMN Number
    K090857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    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. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-00025.

    Additional Manufacturer Narrative · 1

    CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT VISUALLY EXAMINED. PHOTOGRAPHIC IMAGES MADE. COMPLAINT REVIEWED AND ANALYSIS SHOWED NO TREND FOR (B)(4), LOT NO: 754580. DEVICE HISTORY RECORD REVIEWED. (B)(4) - UNDETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY THE INSTRUMENT ARRIVED IN A BROKEN CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALOR(R) TARGETING GUIDE SMALL JOINT INSTRUMENT HSB WRIGHT MEDICAL TECHNOLOGY, INC. 754580

    Patients

    Seq Age Sex Outcome Treatment
    1