BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX? HV-R? BONE CEMENT

    MDR report key: 1897480 · Received November 12, 2010

    Report

    Report Number
    2953769-2010-00578
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    August 31, 2010
    Report Date
    November 4, 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 "OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES WITH AN INTRAVERTEBRAL CLEFT TREATED BY PERCUTANEOUS BALLOON KYPHOPLASTY", BY G. WANG, H. YANG, K. CHEN. METHOD: DEVICE NOT RETURNED; FOLLOWED UP WITH AUTHOR.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE TITLED "OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES WITH AN INTRAVERTEBRAL CLEFT TREATED BY PERCUTANEOUS BALLOON KYPHOPLASTY" THAT: A TOTAL OF 27 PATIENTS (17 WOMEN AND 10 MEN) UNDERWENT BALLOON KYPHOPLASTY BETWEEN (B)(6) 2003 AND (B)(6) 2006. ALL PATIENTS TOLERATED THE PROCEDURE WELL. NO MAJOR PERI-OPERATIVE COMPLICATIONS WERE RECORDED. ASYMPTOMATIC LEAKAGE OF CEMENT INTO THE PARAVERTEBRAL VEIN OCCURRED IN ONE PATIENT AND LEAKAGE INTO THE INTERVERTEBRAL DISC IN ANOTHER PATIENT. PER FOLLOWUP WITH THE AUTHOR: THE CEMENT WAS INJECTED INTO THE VERTEBRAE BEFORE REACHING A DOUGHY STATE. IT IS NOT BELIEVED THAT THE LEAKAGE WAS DUE TO THE CEMENT. IT MAY BE RELATED TO THE VERTEBRAL FRACTURE TYPE AND THE OPERATION TECHNIQUES. NO ADDITIONAL INFORMATION WAS REPORTED. NOTE: HV-R BONE CEMENT IS NOT CURRENTLY DISTRIBUTED IN CHINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX? HV-R? BONE CEMENT BONE CEMENT NDN MEDTRONIC SPINE LLC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR