BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1619636 · Received February 26, 2010

    Report

    Report Number
    2953769-2010-00092
    Event Type
    Malfunction
    Date Received
    February 26, 2010
    Date of Event
    July 21, 2008
    Report Date
    October 29, 2008
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NDN
    PMA / PMN Number
    K033801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED: "VERTEBROPLASTY AND KYPHOPLASTY ARE ASSOCIATED WITH AN INCREASED RISK OF SECONDARY VERTEBRAL COMPRESSION FRACTURES: A POPULATION-BASED COHORT STUDY" BY A.S. MUDANO, J. BIAN, J.U COPE, J.R. CURTIS, T.P. GROSS, J.J. ALLISON, J. KIM, D. BRIGGS, M.E. MELTON, J. XI, K.G. SAAG FROM OSTEOPOROS INTERNATIONAL 2008. METHOD: DEVICE NOT RETURNED, INTERNAL REVIEW OF LITERATURE, FOLLOW-UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED: "VERTEBROPLASTY AND KYPHOPLASTY ARE ASSOCIATED WITH AN INCREASED RISK OF SECONDARY VERTEBRAL COMPRESSION FRACTURES: A POPULATION-BASED COHORT STUDY", THE FOLLOWING EVENTS WERE REPORTED: NINE PTS WITH CEMENT LEAKAGES WERE REPORTED. 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