BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUFF IMPLANT

    MDR report key: 21582511 · Received March 12, 2025

    Report

    Report Number
    3012141159-2025-00114
    Event Type
    Injury
    Date Received
    March 12, 2025
    Date of Event
    February 15, 2025
    Report Date
    March 12, 2025
    Manufacturer
    NORIS MEDICAL LTD
    Product Code
    DZE
    UDI-DI
    07290108812107
    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 NM-F3711, LOT#9000482 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #22 DUE TO LOW TORQUE. A SECONDARY IMPLANT WAS PLACED AFTER REMOVAL. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT IS HEALTHY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926433 TUFF IMPLANT TUFF DENTAL IMPLANT DZE NORIS MEDICAL LTD NM-F3711 9000482 07290108812107

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male