BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA HEAD

    MDR report key: 1050231 · Received May 22, 2008

    Report

    Report Number
    1043534-2008-00117
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    February 20, 2008
    Report Date
    April 30, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    MRA
    PMA / PMN Number
    P030027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ATTEMPTS ARE BEING MADE TO HAVE THE DEVICE RETURNED FOR EVALUATION. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN A FOREIGN COUNTRY.

    Description of Event or Problem · 1

    ALLEGEDLY, HEAD WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINA HEAD MRA WRIGHT MEDICAL TECHNOLOGY, INC. Q0265308

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R