BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1832332 · Received September 3, 2010

    Report

    Report Number
    2953769-2010-00378
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    May 11, 2010
    Report Date
    May 28, 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
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED "PERCUTANEOUS ANTEROLATERAL BALLOON KYPHOPLASTY FOR METASTATIC LYTIC LESIONS OF THE CERVICAL SPINE" BY VASILIS LYKOMITROS, KLEOVOULOS S. ANAGNOSTIDIS, ZIAD ALZEER, GEORGE A. KAPETANOS. DEVICE NOT RETURNED; FOLLOWED-UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "PERCUTANEOUS ANTEROLATERAL BALLOON KYPHOPLASTY FOR METASTATIC LYTIC LESIONS OF THE CERVICAL SPINE", THE PERCUTANEOUS ANTEROLATERAL BALLOON KYPHOPLASTY WERE PERFORMED IN TWO PTS. THE FOLLOWING EVENT WAS REPORTED: ONE PT HAD AN ASYMPTOMATIC CEMENT LEAKAGE IN ONE LEVEL LATERALLY TO C-2 VERTEBRAL. NO ADDITIONAL 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 48 YR LOBECTOMY| CHEMOTHERAPY FOR THE PRIMARY LESION| LOCAL RADIOTHERAPY FOR THE PRIMARY LESION