BEUDAMED
    FDA Adverse Event Death Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 680088 · Received February 17, 2004

    Report

    Report Number
    2953769-2006-00017
    Event Type
    Death
    Date Received
    February 17, 2004
    Date of Event
    February 17, 2004
    Report Date
    February 17, 2004
    Manufacturer
    KYPHON, INC.
    Product Code
    NDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT WITH A HISTORY OF 2 PRIOR VCFS TREATED WITH BALLOON KYPHOPLASTY AND A HISTORY OF STROKE UNDERWENT BALLOON KYPHOPLASTY. THE PHYSICIAN INTENDED TO TREAT 12 LEVELS DURING THE PROCEDURE. DURING THE PROCEDURE, WITHIN MINUTES OF FILLING THE FIRST SET OF 3 VERTEBRAL BODIES WITH BONE CEMENT, THE PT EXPERIENCED AN ACUTE LOSS OF BLOOD PRESSURE. DESPITE RESUSCITATION EFFORTS THE PT DIED. AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX HV-R BONE CEMENT HIGH VISCOSITY, RADIOPAQUE BONE CEMENT NDN KYPHON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death