BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 1639166 · Received March 22, 2010

    Report

    Report Number
    2520274-2010-00040
    Event Type
    Death
    Date Received
    March 22, 2010
    Date of Event
    February 21, 2010
    Report Date
    February 22, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI STERNAL PLATE HRS SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death