BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1619622 · Received February 26, 2010

    Report

    Report Number
    2953769-2010-00087
    Event Type
    Malfunction
    Date Received
    February 26, 2010
    Date of Event
    June 25, 2007
    Report Date
    July 21, 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
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED: "COMPARATIVE STUDY OF BALLOON KYPHOPLASTY WITH UNILATERAL VERSUS BILATERAL APPROACH IN OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES" BY HYUNG JIN CHUNG, KOOK JIN CHUNG, HOI SOO YOON, & IN HYUP KWON INTERNATIONAL ORTHOPAEDICS (SICOT). METHOD, DEVICE NOT RETURNED, INTERNAL REVIEW OF LITERATURE, FOLLOW-UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED, "COMPARATIVE STUDY OF BALLOON KYPHOPLASTY WITH UNILATERAL VERSUS BILATERAL APPROACH IN OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES" REPORTED THE FOLLOWING EVENTS: TWO CASES OF INTRASPINAL CANAL CEMENT LEAKAGE WITHOUT NEUROLOGICAL DEFICIT WITH SUSPICION OF MEDIAL PEDICULAR WALL VIOLATION. NO ADDITIONAL INFORMATION WAS REPORTED. AT THE TIME OF THIS EVENT, KYPHOPLASTY PRODUCTS WERE NOT DISTRIBUTED IN (B)(4).

    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 67 YR