BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL IMPLANT TITANIUM

    MDR report key: 6736537 · Received July 20, 2017

    Report

    Report Number
    MW5071173
    Event Type
    Injury
    Date Received
    July 20, 2017
    Date of Event
    January 3, 2017
    Report Date
    July 20, 2017
    Product Code
    ELJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD TO HAVE A TOOTH IN MY LOWER JAW, FRONT LEFT SIDE, REMOVED DUE TO IT BEING CRACKED. MY DENTIST SUGGESTED A TITANIUM DENTAL IMPLANT. EVERYTHING WAS FINE WITH THE IMPLANT UNTIL I RECEIVED THE CROWN. LITERALLY, THE NEXT DAY, I DEVELOPED A RINGING IN MY LEFT EAR. IT HAS NOT STOPPED SINCE. I HAVE DECIDED TO LEAVE THE IMPLANT THERE FOR NOW, BUT IF IT DOESN'T STOP, I WILL HAVE TO HAVE IT REMOVED. UNFORTUNATELY, WITHIN ABOUT 2 MONTHS, MY RIGHT EAR DEVELOPED TINNITUS PERIODICALLY. MY HEARING HAS ALWAYS BEEN EXCELLENT, UNTIL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511216 DENTAL IMPLANT TITANIUM DENTAL IMPLANT TITANIUM ELJ

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Disability