BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE METAL HOUSING

    MDR report key: 24642779 · Received March 19, 2026

    Report

    Report Number
    3004203816-2026-07720
    Event Type
    Injury
    Date Received
    March 19, 2026
    Date of Event
    March 5, 2026
    Report Date
    March 19, 2026
    Manufacturer
    MIS IMPLANTS TECHNOLOGIES LTD.
    Product Code
    EGG
    UDI-DI
    07290109003986
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE AND THE IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197087 DOUBLE METAL HOUSING ATTACHMENT, PRECISION, ALL EGG MIS IMPLANTS TECHNOLOGIES LTD. W25014633 07290109003986

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention