BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1854298 · Received September 3, 2010

    Report

    Report Number
    2953769-2010-00371
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 6, 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 "KYPHOPLASTY DOES NOT MAINTAIN ALL RESTORED HEIGHT POSTOPERATIVELY: A PROSPECTIVE, COMPARATIVE STUDY", BY YI-LEI ZHAO, MD; HUI-LIN YANG, MD, PHD; JOSEPH KONRAD, BS; JIAYONG LIU, MD; MUHAMMAD MORAL, MS, MBA; YAO-ZENG XU, MD; DE-CHUN GENG, MD; NABIL A. EBRAHEIM, MD. THE ARTICLE DID NOT INDICATE THAT THE BONE CEMENT USED IN THIS IS STUDY IS KYPHX HV-R BONE CEMENT. METHOD - DEVICE NOT RETURNED; FOLLOWED-UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "KYPHOPLASTY DOES NOT MAINTAIN ALL RESTORED HEIGHT POSTOPERATIVELY: A PROSPECTIVE, COMPARATIVE STUDY", 45 FEMALE PTS UNDERWENT BALLOON KYPHOPLASTY FRACTURE. ALL OF THE TREATED VERTEBRAL BODIES WERE LOCATED WITHIN THE THORACOLUMBAR REGION (T11-L2). THE FOLLOWING EVENT WAS REPORTED: CEMENT EXTRAVASATION WAS OBSERVED IN 20% (9/45 OF THE TREATED FRACTURES, BUT NONE OF THE LEAKS WERE ASSOCIATED WITH ANY CLINICAL CONSEQUENCE. NO ADDITIONAL INFO WAS REPORTED. NOTE: THIS ARTICLE ORIGINATED IN (B)(6); HOWEVER, KYPHOPLASTY PRODUCTS ARE NOT DISTRIBUTED IN (B)(6).

    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