BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUFF UNICON IMPLANT

    MDR report key: 22989220 · Received September 7, 2025

    Report

    Report Number
    3011390931-2025-00442
    Event Type
    Malfunction
    Date Received
    September 7, 2025
    Report Date
    September 7, 2025
    Manufacturer
    NORIS MEDICAL LTD
    Product Code
    DZE
    UDI-DI
    07290116153421
    PMA / PMN Number
    K240202
    Product Problem
    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#9001548 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 NMCF4211 LOT#9001548 IMPLANT PACKAGE FAULTY (IMPLANT WAS NOT CONNECTED TO THE HOLDER). THE IMPLANT WASN'T USED.THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799600 TUFF UNICON IMPLANT TUFF UNICON DENTAL IMPLANT DZE NORIS MEDICAL LTD NMCF4211 9001548 07290116153421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown