BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M4 INTERNAL HEX. IMPLANT DIA. 4.20 L 11.50MM

    MDR report key: 24270110 · Received February 5, 2026

    Report

    Report Number
    3004203816-2026-03623
    Event Type
    Injury
    Date Received
    February 5, 2026
    Date of Event
    January 16, 2026
    Report Date
    February 5, 2026
    Manufacturer
    MIS IMPLANTS TECHNOLOGIES LTD.
    Product Code
    DZE
    UDI-DI
    07290108991703
    PMA / PMN Number
    K180282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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

    MIS WARRANTY. IMPLANT FAILURE. SF (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331849 M4 INTERNAL HEX. IMPLANT DIA. 4.20 L 11.50MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE MIS IMPLANTS TECHNOLOGIES LTD. UNK 07290108991703

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention NOT PROVIDED