BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 2328536 · Received November 8, 2011

    Report

    Report Number
    2953769-2011-00151
    Event Type
    Malfunction
    Date Received
    November 8, 2011
    Report Date
    October 11, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PVCS-TWENTY EIGHT OF THE PATIENTS WERE FEMALE AND 3 WERE MALES; KPS-FIFTEEN OF THE PATIENTS WERE FEMALE AND EIGHT WERE MALES. (B)(6). REPORT SOURCE: ABSTRACT TITLED "KYPHOPLASTY VERSUS PERCUTANEOUS VERTEBROPLASTY USING THE TRADITIONAL AND THE NEW SIDE-OPENING CANNULA FOR OSTEOPOROTIC VERTEBRAL FRACTURE", BY NICANDRO FIGUEIREDO, MD, DOUGLAS GONSALES, MD, LUIZ CASULARI, MD. FOLLOW-UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IN AN ABSTRACT TITLED "KYPHOPLASTY VERSUS PERCUTANEOUS VERTEBROPLASTY USING THE TRADITIONAL AND THE NEW SIDE-OPENING CANNULA FOR OSTEOPOROTIC VERTEBRAL FRACTURE", THE RESULTS OF TWO DIFFERENT TYPES OF PERCUTANEOUS VERTEBROPLASTY AND KYPHOPLASTY TO OSTEOPOROTIC VERTEBRAL FRACTURES, FOCUSING AT THE RISK OF CEMENT EXTRUSION WERE ANALYZED. PVS WERE PERFORMED USING THE FRONTAL-OPENING CANNULA (FOC) AND USING THE NEW SIDE-OPENING CANNULA (SOC), RANDOMLY DISTRIBUTED IN THE PV GROUP. A TOTAL OF 47 PVS IN 30 PATIENTS AND 41 KPS PERFORMED IN 24 PATIENTS WERE INCLUDED. THE FOLLOWING WAS REPORTED IN THE RESULTS. AMONG THE 23 CASES OF CEMENT LEAKAGE WITH PV, THERE WERE SOME PROCEDURES IN WHICH THERE WERE MORE THAN ONE LEAKAGE, DISTRIBUTED AS FOLLOWS: FOUR CASES INTO THE DISK WITH THE SOC AND SIX WITH THE FOC; THREE WITH THE SOC AND TEN WITH THE FOC TO THE PARA-VERTEBRAL SPACE; TWO CASES OF EPIDURAL CEMENT EXTRUSION WITH THE FOC AND NONE WITH THE SOC; ONE CASE OF LUNG CEMENT EMBOLISM WITH THE FOC AND NONE WITH THE SOC. AMONG THE 6 CASES OF CEMENT LEAKAGE WITH KP: FOUR CASES OCCURRED INTO THE PARA-VERTEBRAL SPACE; ONE TO THE DISK AND ONE TO THE EPIDURAL SPACE. NO FURTHER INFORMATION WAS REPORTED. NOTED: THE ABSTRACT INDICATED POLYMETHYL METHACRYLATE (PMMA) CEMENT WAS INJECTED IN THE PATIENTS; HOWEVER, DID NOT INDICATE IF PMMA CEMENT WAS KYPHON HV-R CEMENT.

    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 00077 YR