BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1619632 · Received February 26, 2010

    Report

    Report Number
    2953769-2010-00094
    Event Type
    Malfunction
    Date Received
    February 26, 2010
    Date of Event
    November 4, 2008
    Report Date
    January 29, 2009
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NDN
    PMA / PMN Number
    K033801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: AN ARTICLE TITLED "BALLOON KYPHOPLASTY COMBINED WITH POSTERIOR INSTRUMENTATION FOR THE TREATMENT OF BURST FRACTURES OF THE SPINE - 1-YEAR RESULTS" BY ROBERT PFLUGMACHER, MD; AGARWAL, ANAND MD; KANDZIORA, FRANK PD; K. -KLOSTERMANN, PUBLISHED IN THE JOURNAL OF ORTHOPAEDIC TRAUMA, VOL.213(2), FEB 2009, PP 126-131, R. METHOD - DEVICE NOT RETURNED, INTERNAL REVIEW OF LITERATURE, FOLLOW-UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "BALLOON KYPHOPLASTY COMBINED WITH POSTERIOR INSTRUMENTATION FOR THE TREATMENT OF BURST FRACTURES OF THE SPINE - 1-YEAR RESULTS", THE FOLLOWING EVENT WAS REPORTED: IN TWO OF TWENTY-FIVE VERTEBRAL BODIES, ASYMPTOMATIC CEMENT LEAKAGE WAS DETECTED. ONE, A CASE OF ASYMPTOMATIC PARAVERTEBRAL CEMENT LEAKAGE INTO THE LOCAL VENOUS SYSTEM OCCURRED. 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 59 YR