BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA PLUS SPINE SYSTEM INSTRUMENTS

    MDR report key: 16525479 · Received March 10, 2023

    Report

    Report Number
    3004176895-2023-00001
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    November 8, 2022
    Report Date
    February 13, 2023
    Manufacturer
    BK MEDITECH CO., LTD.
    Product Code
    NKB
    PMA / PMN Number
    K183080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UF/IMPORTER # : (B)(4).

    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. ONE PATIENT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443862 MEGA PLUS SPINE SYSTEM INSTRUMENTS BALL POINT TESTER (SPINAL SURGICAL INSTRUMENT) NKB BK MEDITECH CO., LTD. 51680-20 S2009 (MFG. DATE: 09-01--2020)

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Prefer Not To Disclose