BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1856720 · Received September 14, 2010

    Report

    Report Number
    2953769-2010-00392
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    April 20, 2010
    Report Date
    August 31, 2010
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NDN
    PMA / PMN Number
    K041584
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED "A PROSPECTIVE COMPARATIVE STUDY OF KYPHOPLASTY USING THE JACK VERTEBRAL DILATOR AND BALLOON KYPHOPLASTY FOR THE TREATMENT OF OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES", BY G. W. SHEN, N. Q. WU, N. P. ZHANG, Z. S. JIN, J. XU, G. Y. YIN. METHOD: DEVICE WAS NOT RETURNED; FOLLOWED UP WITH COMPANY REP.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "A PROSPECTIVE COMPARATIVE STUDY OF KYPHOPLASTY USING THE JACK VERTEBRAL DILATOR AND BALLOON KYPHOPLASTY FOR THE TREATMENT OF OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES", THE FOLLOWING EVENTS WERE NOTED: TWO ASYMPTOMATIC SMALL LEAKS OF BONE CEMENT IN ONE VERTEBRAL BODY IN THE DILATOR KYPHOPLASTY GROUP; AND FOUR VERTEBRAL BODY CEMENT LEAKAGES, BUT WITHOUT CLINICAL SYMPTOMS IN THE BALLOON KYPHOPLASTY GROUP. NOTE: POLYMETHYLMETHACRYLATE (PMMA) WAS USED, HOWEVER, IT IS UNK IF IT WAS HV-R BONE CEMENT. NOTE: MEDTRONIC SPINE, LLC DOES NOT CURRENTLY DISTRIBUTE PRODUCT IN (B)(4). 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 UNK