BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA PLUS MIS SPINE SYSTEM

    MDR report key: 16282896 · Received February 2, 2023

    Report

    Report Number
    16282896
    Event Type
    Malfunction
    Date Received
    February 2, 2023
    Date of Event
    November 8, 2022
    Report Date
    January 18, 2023
    Manufacturer
    BK MEDITECH CO.,LTD.
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    BK MEDITECH SOUNDER INSTRUMENT BROKE IN PATIENT DURING PLACEMENT OF PATIENT SCREWS. SURGEON ATTEMPTED TO RETRIEVE THE BROKEN PIECE OF THE INSTRUMENT IN THE BONE AND DETERMINED IT TO BE SAFER TO LEAVE THE PIECE IN PLACE. BK MEDITECH VENDOR REPRESENTATIVE AWARE. THE BK MEDITECH SOUNDER INSTRUMENT REMOVED FROM USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387697 MEGA PLUS MIS SPINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB BK MEDITECH CO.,LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 6935 DA Unknown