BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-CENTRIX ULNAR HEAD

    MDR report key: 1050336 · Received May 23, 2008

    Report

    Report Number
    1043534-2008-00120
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    January 30, 2007
    Report Date
    May 6, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KXE
    PMA / PMN Number
    K020274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ADD'L INFO HAS BEEN REQUESTED. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. THIS EVEN OCCURRED IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    ALLEGEDLY PT REVIEWED IN JANUARY DUE TO PAIN AND SWELLING. CLINICALLY PRESENTING AS "OVERSTUFFING", SO HEAD REVISED TO 16MM X 1.5 HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E-CENTRIX ULNAR HEAD KXE WRIGHT MEDICAL TECHNOLOGY, INC. 056299932

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R