BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED CONTROL I-BASE

    MDR report key: 3769624 · Received September 2, 2014

    Report

    Report Number
    2921578-2014-00024
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    August 9, 2014
    Report Date
    September 12, 2014
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER THE SPINAL PROCEDURE WAS COMPLETED, AND THE SURGICAL STAFF WERE MOVING THE PATIENT FROM THE SPECIALTY SURGICAL TABLE TO THE CART, THE TOP HALF OF THE TABLE LOWERED UNEXPECTEDLY. THE PATIENT REMAINED ON THE PLATFORM. THE SURGICAL STAFF LIFTED THE PATIENT UP TO MOVE THE PATIENT ON TO THE CART. THERE WAS NO HARM TO THE PATIENT. INSPECTION FOUND T-PINS INSTALLED INCORRECTLY ON THE TOP RESULTING IN THE TOP TO FALL FROM THE BASE. THE STAFF HAS STATED THAT THE PROCESS THEY USED TO ASSURE ALL T-PINS WERE INSTALLED CORRECTLY WAS NOT FOLLOWED. STAFF WAS RETRAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532342 ADVANCED CONTROL I-BASE TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 5803

    Patients

    Seq Age Sex Outcome Treatment
    1 Other