BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUFF IMPLANT

    MDR report key: 24746670 · Received March 31, 2026

    Report

    Report Number
    3011390931-2026-00108
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    January 15, 2026
    Report Date
    March 31, 2026
    Manufacturer
    NORIS MEDICAL LTD
    Product Code
    DZE
    UDI-DI
    07290108812220
    PMA / PMN Number
    K140440
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN COMPLETED, EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF MISSING EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING REASON OF IMPLANT REMOVAL. THE DHR WAS REVIEWED FOR LOT#9000797, AND NO EVIDENCE WAS DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. ON (B)(6) 2026, IMPLANT FAILED WAS REPORTED WITHOUT REASON. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED. BASED ON THE AVAILABLE INFORMATION THE EXACT ISSUE COULD NOT BE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269089 TUFF IMPLANT TUFF DENTAL IMPLANT DZE NORIS MEDICAL LTD NM-F4220 9000797 07290108812220

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male