BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUFF PRO IMPLANT

    MDR report key: 21729378 · Received March 31, 2025

    Report

    Report Number
    3012141159-2025-00184
    Event Type
    Injury
    Date Received
    March 31, 2025
    Date of Event
    March 5, 2025
    Report Date
    March 31, 2025
    Manufacturer
    NORIS MEDICAL LTD
    Product Code
    DZE
    UDI-DI
    07290108817058
    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 NMAF4216 LOT#9000580 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #15 DUE TO BONE TOO SOFT. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT IS SMOKER THE PATIENT HAS THYROID THERAPY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041736 TUFF PRO IMPLANT TUFF PRO DENTAL IMPLANT DZE NORIS MEDICAL LTD NMAF4216 9000580 07290108817058

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female