BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOCISION 120V

    MDR report key: 6493985 · Received April 14, 2017

    Report

    Report Number
    9611253-2017-00018
    Event Type
    Injury
    Date Received
    April 14, 2017
    Date of Event
    February 23, 2017
    Report Date
    October 17, 2017
    Manufacturer
    NAKANISHI INC.
    Product Code
    EBW
    PMA / PMN Number
    K020327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON AUGUST 8, 2017, NAKANISHI ATTEMPTED TO OBTAIN INFORMATION ABOUT THE PATIENT'S AGE AND WEIGHT FROM THE DISTRIBUTOR, HOWEVER THE INFORMATION WAS NOT PROVIDED. DUE TO THE DEVICE NOT BEING RETURNED FROM THE DISTRIBUTOR, NAKANISHI INC., (B)(4) (MANUFACTURER) MADE THE DHR EXAMINATION AS THE INVESTIGATION APPROACH. AS A RESULT OF THE EXAMINATION, THE DHR INDICATED THAT NO PROBLEMS OCCURRED DURING MANUFACTURING AND TESTING OF THE SUBJECT DEVICE.

    Additional Manufacturer Narrative · 1

    NAKANISHI DID NOT RECEIVE INFORMATION ABOUT THE PATIENT'S AGE AND WEIGHT.

    Description of Event or Problem · 1

    ON MARCH 22, 2017, NAKANISHI RECEIVED AN E-MAIL FROM A DISTRIBUTOR ((B)(4)) ABOUT A PROBLEM WITH AN NSK ORAL SURGICAL UNIT. DETAILS ARE AS FOLLOWS. - THE EVENT OCCURRED ON (B)(6) 2017. - A DENTIST WAS PERFORMING AN ORAL SURGERY ON A PATIENT USING OSSEOCISION TTF120. - SUDDENLY, THE ERROR CODE 3 APPEARED ON THE MONITOR, AND THE DRILL UNIT DID NOT WORK. - THE DENTIST DISCONTINUED THE PROCEDURE AND SENT THE PATIENT HOME. - THE PATIENT WILL BE RETURNED TO THE DENTAL OFFICE WHEN THE UNIT IS REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274781 OSSEOCISION 120V CONTROLLER, FOOT, HANDPIECE AND CORD EBW NAKANISHI INC. OSSEOCISION 120V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other