BEUDAMED
    FDA Adverse Event Other Summary report: N

    KYPHX X HV-R BONE CEMENT

    MDR report key: 619360 · Received July 1, 2005

    Report

    Report Number
    2953769-2005-00009
    Event Type
    Other
    Date Received
    July 1, 2005
    Date of Event
    May 17, 2005
    Report Date
    June 3, 2005
    Manufacturer
    KYPHON, INC.
    Product Code
    NDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE TREATING PHYSICIAN REPORTED THAT THE PATIENT WITH AN OSTEOPOROTIC VERTEBRAL BODY COMPRESSION FRACTURED OF L2 TREATED WITH BALLOON KYPHOPLASTY. BALLON INFLATION WITH THE IBT WAS SUCCESSFUL AND ROUTINE. AT THE END OF KYPHX HV-R BONE CEMENT DELIVERY, AN ANTERIOR CEMENT EXTRAVASATION WAS NOTED. THE EXTRAVASATION APPEARED ON FLUOROSCOPY TO HAVE A ROUND SHAPE CONSISTEN WITH LEAKAGE INTO PREVERTEBRAL VEIN. THE PATIENT DID WELL AND WENT HOME THE NEXT DAY. ONE WEEK LATER AT ROUTINE FOLLOW-UP, X-RAY SHOWED CEMENT LEAKAGE. CT SCAN CONFIRMED CEMENT LEAKAGE FROM THE VERTEBRAL BODY THROUGH THE RIGHT HEART INTO THE PULMONARY ARTERY. THE PATIENT HAS NO SYMPTOMS. TO DATE, THE PATIENT HAS NOT UNDERGONE ANY SPECIFIC TREATMENT FOR THIS CEMENT EXTRAVASATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other