BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 2328541 · Received November 8, 2011

    Report

    Report Number
    2953769-2011-00152
    Event Type
    Malfunction
    Date Received
    November 8, 2011
    Date of Event
    May 19, 2011
    Report Date
    October 13, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PVP-N = 58 PATIENTS, (B)(6); PKP-N = 55 PATIENTS, (B)(6); CMT-N = 55 PATIENTS, (B)(6). REPORT SOURCE: ARTICLE TITLED "OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES: SURGERY VERSUS NON-OPERATIVE MANAGEMENT", H TANG, J ZHAO AND C HAO. FOLLOW-UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES: SURGERY VERSUS NON-OPERATIVE MANAGEMENT", A 12-MONTH RETROSPECTIVE STUDY COMPARED PAIN RELIEF, QUALITY OF LIFE (QOL), TREATMENT COST-EFFECTIVENESS AND COMPLICATION RATES IN PATIENTS UNDERGOING PERCUTANEOUS VERTEBROPLASTY (PVP), PERCUTANEOUS KYPHOPLASTY (PKP), OR CONSERVATIVE MEDICAL THERAPY (CMT). THE FOLLOWING WAS REPORTED. IN 14 (12.4%) PATIENTS (10 PVP AND FOUR PKP), MILD ASYMPTOMATIC LEAKAGE OF POLYMETHYLMETHACRYLATE CEMENT WAS OBSERVED, WHICH REQUIRED NO ADDITIONAL THERAPY. NO FURTHER INFORMATION WAS REPORTED. NOTE: THE ARTICLE INDICATED POLYMETHYLMETHACRYLATE CEMENT; HOWEVER, DID NOT INDICATE THE CEMENT WAS KYPHON HV-R CEMENT. IN ADDITION, BALLOON KYPHOPLASTY PRODUCTS ARE CURRENTLY NOT DISTRIBUTED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SPINE LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1