BEUDAMED
    FDA Adverse Event Death Summary report: N

    STRYKER

    MDR report key: 1063494 · Received June 20, 2008

    Report

    Report Number
    MW5007376
    Event Type
    Death
    Date Received
    June 20, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 7, 2008
    Manufacturer
    STRYKER
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER EXPANDABLE TITANIUM CAGE PROSTHESIS MQP STRYKER SC08-3636 *
    2 SYNTHES, INC SYNTHES SPINE KWQ SYNTHES INC SB08-403

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death