BEUDAMED
    FDA Adverse Event Death Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1712820 · Received June 4, 2010

    Report

    Report Number
    2953769-2010-00206
    Event Type
    Death
    Date Received
    June 4, 2010
    Date of Event
    May 11, 2010
    Report Date
    May 11, 2010
    Manufacturer
    MEDTRONIC SPINE, LLC.
    Product Code
    NDN
    PMA / PMN Number
    K041584
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - DEVICE NOT RETURNED; FOLLOWED UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A THREE-LEVEL BALLOON KYPHOPLASTY PROCEDURE AT LEVELS L1, L3, AND L4. REPORTEDLY, WHILE THE FIRST TWO LEVELS HAD BEEN ACCESSED AND LEVEL L1 WAS FILLED WITH BONE CEMENT, THE PHYSICIAN REALIZED THAT THE PT WAS NOT BREATHING. IT WAS NOTED THAT THERE WAS NO PRODUCT MALFUNCTIONS AND EVERYTHING WORKED AS INTENDED. REPORTEDLY, THE CAUSE OF DEATH IS NOT AVAILABLE. NO ADD'L INFO WAS REPORTED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening