BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUFF IMPLANT

    MDR report key: 19737495 · Received July 14, 2024

    Report

    Report Number
    3011390931-2024-00507
    Event Type
    Malfunction
    Date Received
    July 14, 2024
    Report Date
    July 14, 2024
    Manufacturer
    NORIS MEDICAL LTD
    Product Code
    DZE
    UDI-DI
    07290108812114
    PMA / PMN Number
    K140440
    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#9000843 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.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED ABOUT FAULTY PACKAGING OF THE IMPLANT NM-F3713 LOT#9000843. THE IMPLANTS 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
    1391154 TUFF IMPLANT TUFF DENTAL IMPLANT DZE NORIS MEDICAL LTD NM-F3713 9000843 07290108812114

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown