BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUFF UNICON IMPLANT

    MDR report key: 21640660 · Received March 19, 2025

    Report

    Report Number
    3012141159-2025-00139
    Event Type
    Injury
    Date Received
    March 19, 2025
    Date of Event
    February 6, 2025
    Report Date
    March 19, 2025
    Manufacturer
    NORIS MEDICAL LTD
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT NMCF4208 LOT#9001041 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #2. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2363 TUFF UNICON IMPLANT TUFF UNICON DENTAL IMPLANT DZE NORIS MEDICAL LTD NMCF4208 9001041

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male