BEUDAMED
    FDA Adverse Event Death Summary report: N

    NORIAN CRS

    MDR report key: 1445153 · Received August 17, 2009

    Report

    Report Number
    1445153
    Event Type
    Death
    Date Received
    August 17, 2009
    Date of Event
    August 17, 2007
    Report Date
    July 31, 2009
    Manufacturer
    SYNTHES
    Product Code
    NDN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A FEMALE WHO EXPERIENCED INTRAOPERATIVE DEATH, DUE TO SEVERE PULMONARY EMBOLISM (PE) (CEMENT AND FAT) DURING MAJOR SPINE SURGERY INCLUDING CORPECTOMIES, LAMINECTOMIES, FUSION AND VERTEBROPLASTIES. THE PT ALSO DEVELOPED INTRAOPERATIVE DISSEMINATED INTRAVASCULAR COAGULOPATHY (DIC). PE WAS RECOGNIZED MINUTES AFTER NORIAN TM WAS INJECTED INTO THE VERTEBRAL BODIES. DIC DEVELOPED APPROX 30-45 MINUTES AFTER PE. AFTER THESE EVENTS, THE PT WAS TREATED WITH PRESSORS, MECHANICAL VENTILATION AND MASSIVE TRANSFUSION, BUT DEVELOPED CARDIOPULMONARY COLLAPSE WITHOUT RESPONSE TO APPROPRIATE RESUSCITATIVE EFFORTS. AN AUTOPSY WAS PERFORMED, FINDING FAT AND CEMENT FRAGMENTS IN THE PULMONARY VASCULATURE. DOSE, FREQUENCY & ROUTE USE: INTRAVERTEBRAL. THERAPY DATES: 2007. DIAGNOSIS FOR USE: TO HARDEN VERTEBRAL BODIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORIAN CRS BONE CEMENT NDN SYNTHES N765402
    2 NORIAN CRS BONE CEMENT NDN SYNTHES N707401

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death METHYLMETHACRYLATE