BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M5B-13375

    MDR report key: 21329527 · Received February 6, 2025

    Report

    Report Number
    3004203816-2025-06679
    Event Type
    Injury
    Date Received
    February 6, 2025
    Date of Event
    January 14, 2025
    Report Date
    February 6, 2025
    Manufacturer
    MIS IMPLANTS TECHNOLOGIES LTD.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT EVALUATED BECAUSE THE ISSUE IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311905 M5B-13375 IMPLANT, ENDOSSEOUS, ROOT-FORM DZE MIS IMPLANTS TECHNOLOGIES LTD. N/A W18000647

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention