BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS RADIOLUCENT IMAGING TOP

    MDR report key: 21532060 · Received March 5, 2025

    Report

    Report Number
    2921578-2025-00005
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    February 26, 2025
    Report Date
    April 8, 2025
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE INFORMATION OBTAINED FROM THE INVESTIGATION, THERE WERE NO PROBLEMS REPORTED WITH THE DEVICE. THE T-PIN THAT HOLDS THE TABLETOP TO THE TABLE BASE WAS INCORRECTLY INSERTED BY USER PRIOR TO THE SURGERY THUS CAUSING THE PATIENT TO FALL ALONG WITH THE TABLETOP. THE IFU/OWNER'S MANUAL HAS SUFFICIENT INSTRUCTIONS AND WARNINGS PERTAINING TO THE INTENDED USAGE OF THE T-PIN WITH THE TABLE BASE. AN EDUCATIONAL IN-SERVICE WAS PERFORMED BY THE MANUFACTURER ON 03/06/2025 AT THE HOSPITAL REGARDING THE CORRECT USAGE OF THE T-PIN AND THE DEVICE.

    Description of Event or Problem · 0

    WHEN SETTING UP FOR AN ACDF PROCEDURE USING A MIZUHO OSI MTS TABLE BASE AND IMAGING TABLE TOP, THE TABLE TOP FELL. CUSTOMER ALSO REPORTED THAT THE T-PIN WAS NOT CORRECTLY INSERTED AND THAT THEY BELIEVE USER ERROR IS POSSIBLE. CUSTOMER REPORTED THAT THE PATIENT IS OKAY.

    Description of Event or Problem · 0

    WHEN SETTING UP FOR AN ACDF PROCEDURE USING A MIZUHO OSI MTS TABLE BASE AND IMAGING TABLE TOP, THE TABLE TOP FELL. CUSTOMER ALSO REPORTED THAT THE T-PIN WAS NOT CORRECTLY INSERTED AND THAT THEY BELIEVE USER ERROR IS POSSIBLE. CUSTOMER REPORTED THAT THE PATIENT IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435816 MTS RADIOLUCENT IMAGING TOP OPERATING TABLE JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 5803

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other