BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESTORE SOFT TISSUE IMPLANT

    MDR report key: 496492 · Received November 19, 2003

    Report

    Report Number
    1818910-2003-00750
    Event Type
    Death
    Date Received
    November 19, 2003
    Date of Event
    October 16, 2003
    Report Date
    October 20, 2003
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SHOULDER WAS HOT AND PAINFUL. THE PHYSICIAN WILL PHONE ONCE THE CAUSE OF DEATH HAS BEEN DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SOFT TISSUE IMPLANT ORTHOBIOLOGICS FTM DEPUY ORTHOPAEDICS, INC. NA XW1B81035

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death