BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ATIS EV IMPLANT

    MDR report key: 23208091 · Received October 3, 2025

    Report

    Report Number
    1222802-2025-00028
    Event Type
    Injury
    Date Received
    October 3, 2025
    Date of Event
    September 5, 2025
    Report Date
    October 3, 2025
    Manufacturer
    DENTSPLY IH INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. WHEN THEY REMOVED THE CROWN THE IMPLANT MOVED UP SO THE DOCTOR REMOVED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2457582 UNKNOWN ATIS EV IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention