BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN INTERNAL HEX. IMPLANT DIA. 3.75 L 11.50MM

    MDR report key: 24744387 · Received March 31, 2026

    Report

    Report Number
    3004203816-2026-08808
    Event Type
    Injury
    Date Received
    March 31, 2026
    Report Date
    March 31, 2026
    Manufacturer
    MIS IMPLANTS TECHNOLOGIES LTD.
    Product Code
    DZE
    UDI-DI
    07290108999020
    PMA / PMN Number
    K180282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. CUSTOMER REPORTED. IMPLANT LOSS. SF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801094 SEVEN INTERNAL HEX. IMPLANT DIA. 3.75 L 11.50MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE MIS IMPLANTS TECHNOLOGIES LTD. W25007453 07290108999020

    Patients

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