BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KHYPHON/MEDTRONICS MMPA

    MDR report key: 454022 · Received April 4, 2003

    Report

    Report Number
    MW1028135
    Event Type
    Injury
    Date Received
    April 4, 2003
    Date of Event
    December 29, 2000
    Report Date
    April 4, 2003
    Manufacturer
    KHYPHON
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 6/4/03: TO THE BEST OF CO'S KNOWLEDGE, THE DEVICE IDENTIFIED AS BONE CEMENT, BRAND NAME: KHYPHON/MEDTRONIC MMPA DOES NOT EXIST. FURTHERMORE, KYPHON INC DOES NOT MANUFACTURE OR DISTRIBUTE BONE CEMENT IN THE U.S. THEREFORE, THE INFO REQUESTED CANNOT BE PROVIDED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KHYPHON/MEDTRONICS MMPA BONE CEMENT LOD KHYPHON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| O| R| S TREATMENT, 240+ MG MORPHINE: MS CONTIN, "MSIR".| 50 PLUS EPIDURAL STEROID BLOCKS AS DIAGNOSIS AND