BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1000486 · Received February 20, 2008

    Report

    Report Number
    2953769-2008-00006
    Event Type
    Injury
    Date Received
    February 20, 2008
    Report Date
    January 21, 2008
    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

    METHOD: ROUTINE LITERATURE SEARCH.

    Description of Event or Problem · 1

    A ROUTINE LITERATURE REVIEW REVEALED A CASE REPORT DESCRIBED IN A PUBLISHED ARTICLE DETAILING AN EVENT THAT OCCURRED IN A PATIENT WHO SUBSEQUENT TO A FALL AT HOME PRESENTED WITH OSTEOPOROTIC FRACTURES AT T12 AND L1. AN MRI CONFIRMED FRESH FRACTURES AND REVEALED A SPINAL STENOSIS AT T12/L1. A KYPHOPLASTY AT LEVELS T12 AND L1 WAS PERFORMED. MORE THAN TWO WEEKS AFTER THE PROCEDURE, THE PT WAS ADMITTED TO AN EMERGENCY UNIT WITH INCOMPLETE PARAPLEGIA SUB T8. LABORATORY TESTS REVEALED HIGHLY ELEVATED LEUKOCYTES AND C-REACTIVE PROTEIN. RADIOGRAPHS SHOWED A THIN RADIOLUCENCY AROUND THE CEMENT CORE AT LEVEL T12. AN MRI CONFIRMED A SUSPECTED SPONDYLITIS AND FOUND AN EPIDURAL ABSCESS. THE PT UNDERWENT POSTERIOR DECOMPRESSION FROM LEVELS T10 TO L3 AND ANTERIOR CORPECTOMY OF T12 WITH COMPLETE CEMENT REMOVAL AND IMPLANTATION OF AN EXPANDABLE TITANIUM-CAGE AND BONE GRAFT. AN INCOMPLETE PARAPLEGIA SUB L2 REMAINED.

    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 68 YR Required Intervention