BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUFF UNICON IMPLANT

    MDR report key: 21525397 · Received March 5, 2025

    Report

    Report Number
    3012141159-2025-00084
    Event Type
    Injury
    Date Received
    March 5, 2025
    Date of Event
    January 27, 2025
    Report Date
    March 5, 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 NMCF3713 LOT#9001398 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #20 DUE TO LOW TORQUE. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. A SECONDARY IMPLANT WAS PLACED AFTER REMOVAL. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2314206 TUFF UNICON IMPLANT TUFF UNICON DENTAL IMPLANT DZE NORIS MEDICAL LTD NMCF3713 9001398

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male