BEUDAMED
    FDA Adverse Event Death Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1847905 · Received September 24, 2010

    Report

    Report Number
    2953769-2010-00484
    Event Type
    Death
    Date Received
    September 24, 2010
    Date of Event
    July 3, 2006
    Report Date
    July 12, 2006
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NDN
    PMA / PMN Number
    K033801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD, DEVICE NOT RETURNED, INTERNAL REVIEW OF LITERATURE, FOLLOW-UP WITH AUTHOR.

    Description of Event or Problem · 1

    IT WAS REPORTED A PT UNDERWENT A KYPHOPLASTY PROCEDURE. APPROXIMATELY 10-12 HOURS POST PROCEDURE, THE PT SUDDENLY BECAME HYPOTENSIVE AND SUBSEQUENTLY DIED FROM A THROMBOTIC PULMONARY EMBOLISM. THE PROCEDURE OCCURRED WITHOUT COMPLICATION AND THE PT WAS MOBILE AFTERWARDS. INTRA-OPERATIVE FLUOROSCOPY IMAGES SHOWED NO EVIDENCE OF CEMENT EXTRAVASATION. IT WAS STATED THAT THE PT WAS NOT A WELL PERSON AND WAS SUFFERING FROM "MANY OTHER MEDICAL PROBLEMS". 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