BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1545932 · Received November 23, 2009

    Report

    Report Number
    2953769-2009-00175
    Event Type
    Injury
    Date Received
    November 23, 2009
    Date of Event
    April 28, 2009
    Report Date
    October 29, 2009
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NDN
    PMA / PMN Number
    K033801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED "KYPHOPLASTY FOR PTS WITH MULTIPLE MYELOMA IS A SAFE SURGICAL PROCEDURE: RESULTS FROM A LARGE PT COHORT", BY FRANZ-XAVER HUBER, NICHOLAS MCARTHUR, MICHAEL TANNER, BERND GRITZBACH, OLIVER SCHOIERER, WOLFRAM ROTHFISCHER, GERHARD KROHMER, ERICH LESSL, MARTIN BAIER, PETER JURGEN MEEDER, CHRISTAIN KASPERK. DEVICE NOT RETURNED, F/U WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "KYPHOPLASTY FOR PTS WITH MULTIPLE MYELOMA IS A SAFE SURGICAL PROCEDURE: RESULTS FROM A LARGE PT COHORT", THE DATA OF 76 PTS WITH A TOTAL OF 190 KYPHOPLASTY-TREATED VERTEBRAE WERE ANALYZED RETROSPECTIVELY. THE ARTICLE REPORTED THE FOLLOWING EVENTS: A DORSAL CEMENT LEAKAGE WAS OBSERVED IN 9 LEVELS (5% OF ALL LEVELS), AND IN ONE OF THESE CASES, THE CEMENT LEAKAGE LED TO MOTOR DEFICITS OF BOTH LEGS. IT WAS OBSERVED THAT THE NEUROLOGIC DEFICITS DIMINISHED FOLLOWING SURGICAL REMOVAL OF THE CEMENT. ONE PT EXPERIENCED A PULMONARY EMBOLISM THAT WAS DETECTED IN AN ANTEROPOSTERIOR RADIOGRAPH OF THE THORACIC SPINE; AND CEMENT LEAKAGES WERE OBSERVED IN A TOTAL OF 35 VERTEBRAE (IT IS UNK HOW MANY PTS THIS REPRESENTS AS IT WAS NOT SPECIFICALLY STATED IN THE ARTICLE). THE AUTHORS STATED THAT THE PTS SHOWED NO LOCAL OR SYSTEMIC REACTIONS WITH PMMA. 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 62 YR Other| R