BEUDAMED
    FDA Adverse Event Other Summary report: N

    5803 ADVANCED CONTROL BASE

    MDR report key: 2061034 · Received March 16, 2011

    Report

    Report Number
    2921578-2011-00006
    Event Type
    Other
    Date Received
    March 16, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 15, 2011
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE TO BE EVALUATED AND WILL ADVISE UPON RECEIPT.

    Description of Event or Problem · 1

    DURING REVIEW, IT WAS NOTED THAT THE FLANGE ATTACHED TO THE TELESCOPIC I-BASE ASSEMBLY BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5803 ADVANCED CONTROL BASE OPERATING ROOM TABLE GDC MIZUHO ORTHOPEDIC SYSTEMS, INC. 5803

    Patients

    Seq Age Sex Outcome Treatment
    1 Other