BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1823679 · Received August 26, 2010

    Report

    Report Number
    2953769-2010-00365
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    December 5, 2009
    Report Date
    August 4, 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED "A COMPARATIVE ANALYSIS OF THE RESULTS OF VERTEBROPLASTY AND KYPHOPLASTY IN OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES", BY KRISHNA KUMAR, MB, MS, RITA NGUYEN, BSC, SHARON BISHOP, BNURS, MHSCI. THE ARTICLE DID NOT INDICATE THAT THE BONE CEMENT USED IN THIS IS STUDY IS KYPHX HV-R BONE CEMENT. METHOD - DEVICE NOT RETURNED; F/U WITH AUTHOR. REFERENCE MFR REPORT#: 2953769-2010-00354 - 2953769-2010-00370.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "A COMPARATIVE ANALYSIS OF THE RESULTS OF VERTEBROPLASTY AND KYPHOPLASTY IN OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES", A PROSPECTIVE STUDY OF 28 VERTEBROPLASTY PTS AND 24 KYPHOPLASTY PTS TREATED OVER THE PAST 2 YRS WAS PRESENTED. THE FOLLOWING EVENT WAS REPORTED: THE PT UNDERWENT A VERTEBROPLASTY PROCEDURE USING A UNIPEDICULAR APPROACH AT LEVEL L1. CEMENT EXTRAVASATION OCCURRED. THE CEMENT EXTRAVASATION OCCURRED INTO THE INTRADISCAL SPACE, ANTERIOR TO THE VERTEBRAL BODY, ALONG THE NERVE ROOT, AND INTO THE SPINAL CANAL. THERE WERE NO NEUROLOGICAL DEFICIT REPORTED. NO ADD'L 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 86 YR