BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1873516 · Received September 22, 2010

    Report

    Report Number
    2953769-2010-00404
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Report Date
    September 14, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED "BALLOON KYPHOPLASTY IN THE TREATMENT OF METASTATIC TUMORS IN UPPER THORACIC SPINE", MOHAMMED ELERAKY MD, PHD; KIESHA M KATSARES ARNP; MATTHIAS SETZER; MANDY SULLIVAN RN; FRANK D. VRIONIS MD, PHD. METHOD: DEVICE NOT RETURNED; F/U WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ABSTRACT TITLED "BALLOON KYPHOPLASTY IN THE TREATMENT OF METASTATIC TUMORS IN UPPER THORACIC SPINE", THE FOLLOWING WAS REPORTED: 14 PTS UNDERWENT BALLOON KYPHOPLASTY THROUGH POSTERIOR APPROACH FOR MANAGEMENT OF METASTATIC TUMORS IN UPPER THORACIC SPINE (T1-T5). PMMA CEMENT EXTRAVASATIONS WERE OBSERVED IN 3 OUT OF 30 TREATED VERTEBRAL BODIES (10%) WITHOUT ANY CONSEQUENCES. IT WAS CONFIRMED THAT HV-R BONE CEMENT WAS USED FOR THE PROCEDURES. 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 UNK