BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALTIUS MINI

    MDR report key: 1752800 · Received July 12, 2010

    Report

    Report Number
    2242816-2010-00091
    Event Type
    Death
    Date Received
    July 12, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 9, 2010
    Manufacturer
    EBI, LLC
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT C1 POSTERIOR CERVICAL FUSION, DUE TO C1-C2 INSTABILITY. REP REPORTS THAT POST-SURGERY, THE HOSPITAL WAS UNABLE TO WAKE THE PATIENT WHO WAS APPARENTLY BRAIN DEAD. ACCORDING TO THE REP, THE HOSPITAL CONCLUDED THAT AN ARTERY WAS SEVERED DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTIUS MINI KWP EBI, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death