BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1344664 · Received March 11, 2009

    Report

    Report Number
    2953769-2009-00019
    Event Type
    Injury
    Date Received
    March 11, 2009
    Report Date
    February 12, 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: "1150 KYPHOPLASTIES OVER 7 YEARS: INDICATIONS, TECHNIQUES, AND INTRAOPERATIVE COMPLICATIONS" BY NICHOLAS MCARTHUR, MD CHRISTIAN KASPERK, MD; MARTIN BAIER, MD; MICHAEL TANNER, MD; BERND GRITZBACH, MD; OLIVER SCHOIERER, MD; WOLFRAM ROTHFISCHER, MD; GERHARD KROHMER, MD; JOCHEN HILMEIER, MD; HANS-JURGEN KOCK, MD; PETER JURGEN MEEDER, MD; FRANZ-XAVER HUBER, MD TAKEN FROM ORTHO SUPERSITE, ORTHOPEDICS 2009;32:90. METHOD - OTHER, DEVICE NOT RETURNED, INTERNAL REVIEW OF LITERATURE.

    Description of Event or Problem · 1

    IN A LITERATURE REVIEW, IT WAS REPORTED THAT AFTER A KYPHOPLASTY PROCEDURE, A CT SCAN REVEALED A CASE OF CEMENT LEAKAGE WHICH FILLED 50% OF THE SPINAL CANAL OF THE PATIENT LEADING TO MOTOR DEFICITS OF BOTH LEGS. THE PATIENT HAD MULTIPLE MYELOMA AND A SIGNIFICANT POSTERIOR WALL INSTABILITY. THE NEUROLOGICAL DEFICIT DIMINISHED, FOLLOWING SURGICAL REMOVAL OF THE CEMENT, RESULTING IN NO LONG-TERM NEUROLOGICAL DEFICITS.

    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 Other| R