BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUFF IMPLANT

    MDR report key: 21444966 · Received February 24, 2025

    Report

    Report Number
    3011390931-2025-00085
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    January 20, 2025
    Report Date
    February 24, 2025
    Manufacturer
    NORIS MEDICAL LTD
    Product Code
    DZE
    UDI-DI
    07290108815672
    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

    THE DHR WAS REVIEWED FOR LOT#9000378 AND THERE WAS NO EVIDENCE DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. TO DATE, ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THE INVESTIGATION FOR THIS EVENT HAS NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. OUR MANUFACTURING SYSTEM ASSURES, THAT PRODUCTION AND PROCESS CONTROLS ARE IN PLACE TO ENSURE THAT BATCHES CONFORM TO THE APPLICABLE SPECIFICATIONS BEFORE THEY ARE DISTRIBUTED. 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

    A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4225 LOT#9000378 IMPLANT LACKED PRIMARY STABILITY DUE TO LOW TORQUE. 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
    527545 TUFF IMPLANT TUFF DENTAL IMPLANT DZE NORIS MEDICAL LTD NM-F4225 9000378 07290108815672

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown