BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 1936606 · Received December 22, 2010

    Report

    Report Number
    2953769-2010-00617
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Report Date
    December 9, 2010
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NDN
    PMA / PMN Number
    K041584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED "COMPARISON OF CLINICAL EFFECT BETWEEN PVP AND PKP FOR TREATMENT OF OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES", BY HAO CHEN, YUAN LI, JINJUN LI, BINQIANG WANG, HAI TANG. METHOD - DEVICE NOT RETURNED; FOLLOWED UP WITH AUTHOR.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ABSTRACT TITLED "COMPARISON OF CLINICAL EFFECT BETWEEN PVP AND PKP FOR TREATMENT OF OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES", THAT: 30 PATIENTS UNDERWENT OPERATIONS WITH PVP (PERCUTANEOUS VERTEBROPLASTY) AND 45 UNDERWENT OPERATIONS WITH PKP (PERCUTANEOUS KYPHOPLASTY). THE OPERATIONS WERE SUCCESSFUL IN ALL PATIENTS. IN 16 CASES OF PVP AND 11 CASES OF PKP, CEMENT LEAKAGE OCCURRED; HOWEVER, WITHOUT CLINICAL SYMPTOMS. NO FURTHER INFORMATION WAS REPORTED. IT IS UNKNOWN IF THE BONE CEMENT USED WAS HV-R. NOTE: MEDTRONIC SPINE, LLC DOES NOT CURRENTLY DISTRIBUTE PRODUCT IN CHINA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SPINE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1