BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1456754 · Received August 27, 2009

    Report

    Report Number
    2953769-2009-00111
    Event Type
    Injury
    Date Received
    August 27, 2009
    Date of Event
    July 28, 2009
    Report Date
    July 28, 2009
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    LOD
    PMA / PMN Number
    K033801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED, FOLLOW UP CONVERSATION WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    DURING A SINGLE LEVEL KYPHOPLASTY PROCEDURE AT LEVEL UNKNOWN, IT WAS REPORTED THAT CEMENT EXTRAVASATED THROUGH THE VERTEBRAL BODY SIDEWALL INTO A SEGMENTAL VEIN, AND BECAME LODGED IN THE VENA CAVA. THE PATIENT'S STATUS WAS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX HV-R BONE CEMENT HIGH VISCOSITY, RADIOPAQUE BONE CEMENT LOD MEDTRONIC SPINE LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other