BEUDAMED
    FDA Adverse Event Death Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1833157 · Received September 3, 2010

    Report

    Report Number
    2953769-2010-00381
    Event Type
    Death
    Date Received
    September 3, 2010
    Date of Event
    July 30, 2007
    Report Date
    August 1, 2007
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NDN
    PMA / PMN Number
    K041584
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED; F/U WITH COMPANY REP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A KYPHOPLASTY PROCEDURE AT LEVELS L4 AND L5. REPORTEDLY, THE PROCEDURE WAS 40 MINUTES WITHOUT ANY COMPLICATIONS AND THE PT "WAS FINE DURING RECOVERY". PRE-OPERATIVELY, THE PT WAS ADJUSTED ON THE TABLE TO "SATISFY HIS OXYGEN STATUS AND BLOOD PRESSURE." THE CASE "APPEARED TO GO WELL AND THE PT WAS REPOSITIONED ON HIS BED AND TAKEN TO RECOVERY. AT 8:00 PM, THE PT WAS "FEELING GOOD AND APPEARED WELL." AT 6:58 AM, THE PT EXPERIENCED A CARDIAC ARREST AND EXPIRED. NO ADDITIONAL INFORMATION 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 UNK Life Threatening