BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL IMPLANT NEODENT

    MDR report key: 19820037 · Received July 23, 2024

    Report

    Report Number
    MW5157516
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    June 30, 2023
    Report Date
    July 18, 2024
    Manufacturer
    STRAUMANN MANUFACTURING, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023 DENTAL IMPLANT PLACED #14. THE AREA OF MY TONGUE BY THE IMPLANT HAS BEEN SWOLLEN AND SCRATCHY EVER SINCE. I HAVE TO SLEEP A CERTAIN WAY, SO I DON'T FEEL LIKE I'M GAGGING ON MY TONGUE. NO ONE KNOWS WHAT TO DO ABOUT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357302 DENTAL IMPLANT NEODENT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE STRAUMANN MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Disability| O