BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1619628 · Received February 26, 2010

    Report

    Report Number
    2953769-2010-00097
    Event Type
    Malfunction
    Date Received
    February 26, 2010
    Date of Event
    January 27, 2009
    Report Date
    June 15, 2009
    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: "SINGLE-BALLOON KYPHOPLASTY IN OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES: FAR-LATERAL EXTRAPEDICULAR APPROACH" BY KYEONG-SIK RYU, M. D. , HAN-YONG HUH, M.D., SUNG-CHUL JUN, M.D., CHUN KIN PARK, M.D., PH.D. METHOD - DEVICE NOT RETURNED, INTERNAL REVIEW OF LITERATURE, FOLLOW-UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "SINGLE-BALLOON KYPHOPLASTY IN OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES: FAR-LATERAL EXTRAPEDICULAR APPROACH", THE FOLLOWING EVENTS WERE REPORTED: TWO LEVELS OF INTRADISCAL LEAKS. TWO LEVELS OF LEAKS INTO THE PARAVERTEBRAL MUSCLES. ONE LEAK INTO THE PARAVERTEBRAL VENOUS CHANNEL. REPORTEDLY, "NO PT COMPLAINED OF SYMPTOMS RELATED WITH THE EXTRAVASATIONS." NO ADDITIONAL INFORMATION WAS REPORTED. AT THE TIME OF THESE EVENTS, 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 69 YR