BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C1-13500

    MDR report key: 22584117 · Received July 23, 2025

    Report

    Report Number
    3004203816-2025-31500
    Event Type
    Injury
    Date Received
    July 23, 2025
    Report Date
    July 23, 2025
    Manufacturer
    MIS IMPLANTS TECHNOLOGIES LTD.
    Product Code
    DZE
    UDI-DI
    07290108992151
    PMA / PMN Number
    K112162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    003

    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
    1921326 C1-13500 IMPLANT, ENDOSSEOUS, ROOT-FORM DZE MIS IMPLANTS TECHNOLOGIES LTD. W23016047 07290108992151

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention