BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 515962 · Received March 5, 2004

    Report

    Report Number
    MW1031444
    Event Type
    Malfunction
    Date Received
    March 5, 2004
    Report Date
    March 4, 2004
    Manufacturer
    SMITH & NEPHEW RICHARD, INC.
    Product Code
    IQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ORTHOPAEDIC SPATIAL FRAM WITH STRUTS. STRUTS FAILED - 2 OUT OF 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * STRUTS IQO SMITH & NEPHEW RICHARD, INC. TAYLOR SPATIAL FRAME STRUTS *

    Patients

    Seq Age Sex Outcome Treatment
    1 *