BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MIS

    MDR report key: 21458895 · Received February 25, 2025

    Report

    Report Number
    3004203816-2025-11768
    Event Type
    Injury
    Date Received
    February 25, 2025
    Date of Event
    October 10, 2024
    Report Date
    February 25, 2025
    Manufacturer
    MIS IMPLANTS TECHNOLOGIES LTD.
    Product Code
    DZE
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. THIS MDR REPORT IS A LATE SUBMISSION. A CAPA ((B)(6)) HAS BEEN ISSUED.

    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
    424473 UNK MIS IMPLANT, ENDOSSEOUS, ROOT-FORM DZE MIS IMPLANTS TECHNOLOGIES LTD. W19000695

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention