BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1845759 · Received September 24, 2010

    Report

    Report Number
    2953769-2010-00540
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Report Date
    November 6, 2008
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NDN
    PMA / PMN Number
    K041584
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLE "W4-03: EVAL OF PERCUTANEOUS BALLOON KYPHOPLASTY IN THE TREATMENT OF VERTEBRAL BODY COMPRESSION FRACTURES DUE TO MULTIPLE MYELOMA" BY S. M. JOSHI, M. KHAN, N. K. K. KING, H. ELLAMUSHI & J. YEH. METHOD: DEVICE NOT RETURNED; INTERNAL REVIEW OF LITERATURE; FOLLOWED UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLE " EVAL OF PERCUTANEOUS BALLOON KYPHOPLASTY IN THE TREATMENT OF VERTEBRAL BODY COMPRESSION FRACTURES DUE TO MULTIPLE MYELOMA", THE FOLLOWING EVENTS WERE REPORTED: THREE PTS HAD ASYMPTOMATIC CEMENT EXTRAVASATION. NO ADDITIONAL 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