BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE TOTAL HEAD W/BFH

    MDR report key: 1251273 · Received December 4, 2008

    Report

    Report Number
    1043534-2008-00345
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    November 24, 2008
    Report Date
    November 24, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC
    Product Code
    KWA
    PMA / PMN Number
    K021349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFO HAS BEEN REQUESTED. TRENDS WILL BE EVALUATED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2008-00343, 00344.

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING REVISION OF MODULAR NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE TOTAL HEAD W/BFH KWA WRIGHT MEDICAL TECHNOLOGY, INC NA 04480867

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R