BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1915303 · Received November 2, 2010

    Report

    Report Number
    2953769-2010-00572
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 22, 2010
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NDN
    PMA / PMN Number
    K041584
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ABSTRACT TITLED "PERCUTANEOUS KYPHOPLASTY FOR PALLIATION OF THORACOLUMBAR SPINE FRACTURES DUE TO MALIGNANCY - PROCEDURE INDICATIONS, LIMITATIONS AND RESULTS OUT OF 5 YRS", BY MAX MARKMILLER. METHOD: DEVICE NOT RETURNED; F/U PERFORMED.

    Description of Event or Problem · 1

    IN AN ABSTRACT TITLED "PERCUTANEOUS KYPHOPLASTY FOR PALLIATION OF THORACOLUMBAR SPINE FRACTURES DUE TO MALIGNANCY - PROCEDURE INDICATIONS, LIMITATIONS AND RESULTS OUT OF 5 YRS", THE FOLLOWING WAS REPORTED: FROM (B)(6) 2004 TO (B)(6) 2009 OUT OF 1117 KYPHOPLASTIES, 115 PTS WITH METASTATIC LESIONS WERE TREATED. THE CLINICAL AND RADIOLOGICAL 6 - MONTHS F/U CONFIRMED GOOD RESULTS; HOWEVER, 24 PTS HAD DIED IN BETWEEN. COMPLICATIONS REFER TO EXTRAVASATIONS OF THE CEMENT: TWO PTS SHOWED TEMPORARY RADICULOPATHY. THREE PTS WITH INTERVERTEBRAL DISC PARAVASATION STAYED ASYMPTOMATIC. THREE PTS SHOWED EPIDURAL PARAVASATION WITHOUT NEUROLOGICAL IMPAIRMENT, BUT NO ONCOLOGIC PT REQUIRED SURGICAL REVISION. NOTE: THE ABSTRACT DOES NOT SPECIFY IF PT DEATHS ARE RELATED TO THE KYPHOPLASTY PROCEDURES OR PROGRESSION OF DISEASE. IT IS UNK IF HV-R BONE CEMENT WAS USED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX HV-R BONE CEMENT HIGH VISCOSITY, RADIOPAQUE BONE CEMENT NDN MEDTRONIC SPINE LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK