BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1834435 · Received September 10, 2010

    Report

    Report Number
    2953769-2010-00386
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Report Date
    August 17, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABSTRACT DID NOT INDICATE THAT THE BONE CEMENT USED IN THIS STUDY WAS KYPHX HV-R BONE CEMENT FOR RFK GROUP. REPORT SOURCE: ARTICLE TITLED "ONE-YEAR OBSERVATION STUDY UPON A NEW AUGMENTATION PROCEDURE (RADIOFREQUENCY-KYPHOPLASTY) IN THE TREATMENT OF VERTEBRAL BODY COMPRESSION FRACTURES", BY AW LICHT, W KRAMER. METHOD - DEVICE NOT RETURNED; FOLLOW-UP WITH AUTHOR NOT POSSIBLE AS NO CONTACT INFORMATION PROVIDED. REFERENCE MFR REPORT #: 2953769-2010-00387.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "ONE-YEAR OBSERVATION STUDY UPON A NEW AUGMENTATION PROCEDURE (RADIOFREQUENCY-KYPHOPLASTY) IN THE TREATMENT OF VERTEBRAL BODY COMPRESSION FRACTURES", THE FOLLOWING WAS REPORTED: CEMENT LEAKAGE RATE WAS ON AVERAGE 18.7% IN THE BKP TREATED PATIENTS. ONE CASE OF PULMONARY CEMENT EMBOLIZATION. RADIOFREQUENCY-KYPHOPLASTY (RFK) GROUP SHOWED 12.8% CEMENT LEAKAGE. 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