BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 2171974 · Received July 22, 2011

    Report

    Report Number
    2953769-2011-00089
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NDN
    PMA / PMN Number
    K093828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: FOLLOWED UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE APPEARED TO BE A SLIGHT CEMENT EXTRAVASATION INTO THE DISC SPACE AT T7 AND T10 WHEN FINAL FLUORO IMAGES WERE TAKEN POST KYPHOPLASTY PROCEDURE. THE EXTRAVASATION WAS ASYMPTOMATIC. THE BONE CEMENT WAS STORED AND MIXED ACCORDING TO THE IFU AND WAS INJECTED AT A DOUGHY AND HOMOGENOUS STATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT STATUS WAS GOOD. 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.

    Patients

    Seq Age Sex Outcome Treatment
    1