BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVANCED CONTROL BASE

    MDR report key: 1760472 · Received July 14, 2010

    Report

    Report Number
    2921578-2010-00009
    Event Type
    Other
    Date Received
    July 14, 2010
    Date of Event
    March 18, 2010
    Report Date
    June 10, 2010
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL CONTACT WITH CUSTOMER, LEFT MESSAGE RELATING TO SETUP OF TABLE, POSITIONING OF PT, OUTCOME OF PT AND REQUEST TO HAVE A COMPANY REP REVIEW SETUP TECHNIQUES. WILL UPDATE AS FURTHER INFO IS AVAILABLE. ADD'L INFO: DEVICE #2 JACKSON SPINAL TABLE. MODEL# 5943. CATALOG# 5943.

    Description of Event or Problem · 1

    PT WAS PRONE ON THE JACKSON SPINAL TABLE WITH SLING. AT THE END OF THE PROCEDURE THERE WERE REDDENED AREAS WITH ABRASIONS NOTED IN BILATERAL GROIN AREA. LUMBAR LAMINECTOMY. CUSTOMER STATED "IT WAS A DEVICE MALFUNCTION, THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other