BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED CONTROL I-BASE

    MDR report key: 4479395 · Received January 19, 2015

    Report

    Report Number
    2921578-2015-00002
    Event Type
    Injury
    Date Received
    January 19, 2015
    Date of Event
    October 31, 2013
    Report Date
    January 19, 2015
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT NOTIFIED OUR COO THAT HE HAD INTRACTABLE NECK PAIN FOLLOWING A SURGICAL PROCEDURE ON A MIZUHO OSI SPINAL SURGICAL TABLE. THE PATIENT STATED THAT THE ANESTHESIOLOGIST WAS FOUND INEPT, AND ON DRUGS DURING THE PROCEDURE AND BELIEVES THEY WERE TO BLAME FOR HIS PAIN AND SUFFERING. THE ANESTHESIOLOGIST LATER COMMITTED SUICIDE AND WAS FOUND TO BE ADDICTED TO DRUGS. THE FACILITY IS KNOWN AS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43173 ADVANCED CONTROL I-BASE TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 5803

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O