BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIVA VCF TREATMENT SYSTEM KIT FIRST FRACTURE- LEFT

    MDR report key: 10683361 · Received October 14, 2020

    Report

    Report Number
    MW5097224
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    October 7, 2020
    Report Date
    October 9, 2020
    Manufacturer
    IZI MEDICAL PRODUCTS LLC
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    T12 KYPHOPLASTY WAS COMPLICATED BY TWO FAILURES OF KIVA VCF TREATMENT KIT SYSTEM: FIRST KIT INNER PORTION OF CANNULA COULD NOT BE PLACED ON DEVICE; SECOND KIT 1X1MM PORTION OF PLASTIC CAGE WAS STUCK WITHIN VERTEBRAL BODY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146326 KIVA VCF TREATMENT SYSTEM KIT FIRST FRACTURE- LEFT CEMENT, BONE, VERTEBROPLASTY NDN IZI MEDICAL PRODUCTS LLC 20201889, 19000800

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR