BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMART 360 PISTON, .6MM X 4.25MM

    MDR report key: 2640438 · Received June 28, 2012

    Report

    Report Number
    1037007-2012-00004
    Event Type
    Other
    Date Received
    June 28, 2012
    Date of Event
    December 20, 2011
    Report Date
    June 28, 2012
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    ETB
    PMA / PMN Number
    003214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR RETURN. LOT CONSISTED OF 40 PIECES. NO OTHER ADVERSE EVENTS ON FILE FOR THIS ITEM OR LOT.

    Description of Event or Problem · 1

    SURGEON PERFORMED A STAPEDECTOMY ON PATIENT ON (B)(6) 2010, DURING WHICH THE SURGEON IMPLANTED A SMART 360 STAPES PISTON PROSTHETIC. PT'S HEARING WAS INITIALLY IMPROVED POST-SURGERY, BUT WITHIN A SHORT PERIOD OF TIME THEREAFTER HIS HEARING DECLINED TO THE EXTENT THAT IT WAS WORSE THAN IT HAD BEEN PRE-SURGERY. ON (B)(6) 2011, SURGEON PERFORMED ANOTHER SURGERY AND REPLACED THE SMART 360 STAPES PISTON WITH A RICHARDS STAPES PISTON. SURGEON CLAIMS THE ORIGINAL DEVICE WAS FOUND DETACHED AND WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART 360 PISTON, .6MM X 4.25MM ETB GYRUS ACMI, INC. 0841394698

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention