BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1243721 · Received November 25, 2008

    Report

    Report Number
    2953769-2008-00061
    Event Type
    Injury
    Date Received
    November 25, 2008
    Report Date
    October 31, 2008
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NDN
    PMA / PMN Number
    K033801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER; FOLLOW UP CONVERSATION WITH COMPANY REP. THE FILLING OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT ANY DEVICE DISCUSSED HEREIN CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Description of Event or Problem · 1

    A PT WITH MAJOR CO-MORBIDITIES UNDERWENT A TWO-LEVEL KYPHOPLASTY PROCEDURE AT LEVELS T6, T7. APPROX 10 DAYS POST PROCEDURE, THE PT COMPLAINED OF LOSS OF FEELING AND FUNCTION IN HER LOWER EXTREMITIES. THE TREATING SURGEON EVALUATED THE PT AND OBSERVED OSTEOMYELITIS (EPIDURAL ABSCESS) AT OR NEAR THE PREVIOUSLY TREATED LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX HV-R BONE CEMENT HIGH VISCOSITY, RADIOPAQUE BONE CEMENT NDN MEDTRONIC SPINE LLC. NA EL21708

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other