BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 2080568 · Received May 6, 2011

    Report

    Report Number
    2953769-2011-00055
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NDN
    PMA / PMN Number
    K093828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. REPORT SOURCE: ARTICLE TITLED "PERCUTANEOUS KYPHOPLASTY FOR PALLIATION OF THORACOLUMBAR SPINE FRACTURES DUE TO MALIGNANCY - PROCEDURE INDICATIONS, LIMITATIONS AND RESULTS OUT OF 5 YEARS", BY MAX MARKMILLER. METHOD: FOLLOW-UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "PERCUTANEOUS KYPHOPLASTY FOR PALLIATION OF THORACOLUMBAR SPINE FRACTURES DUE TO MALIGNANCY - PROCEDURE INDICATIONS, LIMITATIONS AND RESULTS OUT OF 5 YEARS", 1,117 KYPHOPLASTIES PERFORMED FROM (B)(6) 2004 TO (B)(6) 2009 WERE REVIEWED. OF THE 1,117 KYPHOPLASTIES REVIEWED, 115 PATIENTS WITH METASTATIC LESIONS WERE TREATED. VISUAL ANALOG SCALE SHOWED A DECREASE OF THE PAIN LEVEL OF 60% IN 80% OF THE PATIENTS. ALL PATIENTS WERE MOBILE WITHOUT ORTHESIS AFTER THE PROCEDURE. THE FOLLOWINGS WERE REPORTED RELATING TO COMPLICATIONS - REFER TO PARAVASATIONS OF THE CEMENT: TWO PATIENTS SHOWED TEMPORARY RADICULOPATHY. THREE PATIENTS WITH INTERVERTEBRAL DISC PARAVASATION STAYED ASYMPTOMATIC. THREE PATIENTS SHOWED EPIDURAL PARAVASATION WITHOUT NEUROLOGICAL IMPAIRMENT, BUT NO ONCOLOGIC PATIENT REQUIRED SURGICAL REVISION. 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. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1