BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 1916007 · Received December 6, 2010

    Report

    Report Number
    2953769-2010-00593
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NDN
    PMA / PMN Number
    K041584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED "NEW USER RESULTS AFTER TREATMENT OF OSTEOPOROTIC VERTEBRAL FRACTURES WITH BALLON KYPHOPLASTIE", BY H. KUNTER, A. JUBEL. METHOD: DEVICE NOT RETURNED; FOLLOWED UP WITH AUTHOR.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ABSTRACT TITLED "NEW USER RESULTS AFTER TREATMENT OF OSTEOPOROTIC VERTEBRAL FRACTURES WITH BALLON KYPHOPLASTIE," THAT: 109 PATIENTS UNDERWENT 143 KYPHOPLASTIES. CEMENT DISLOCATION OCCURRED IN 4% WITHOUT ANY CLINICAL SYMPTOMS. THE ABSTRACT DID NOT INDICATE IF HV-R BONE CEMENT WAS USED FOR THESE PROCEDURES. NO FURTHER INFORMATION WAS REPORTED.

    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 00074 YR