BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ABUTMENT TI

    MDR report key: 25253227 · Received May 22, 2026

    Report

    Report Number
    1222802-2026-00024
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    April 4, 2023
    Report Date
    May 22, 2026
    Manufacturer
    DENTSPLY IH INC.
    Product Code
    NHA
    UDI-DI
    07392532291616
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. DENTSPLY SIRONA BECAME AWARE OF A SERIOUS INJURY THAT OCCURRED WHILE USING THE XIVE IMPLANT SYSTEM. THIS REPORT IS FOR THE DENTAL ABUTMENT DEVICE. THE DENTAL IMPLANT DEVICE REPORT WILL BE SUBMITTED SEPARATELY. PRODUCT RETURN IS REQUESTED AND THEY WILL BE EVALUATED AFTER RECEIPT. IN CASE ANY NEW OR ADDITIONAL INFORMATION WILL BE GAINED FROM THIS INVESTIGATION A FOLLOW-UP REPORT WILL BE SENT. TREND IS TRACKED AND MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL ABUTMENT SCREW AND THE RESULTING FRAGMENT LED TO THE EXPLANTATION OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480950 ATLANTIS ABUTMENT TI ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA DENTSPLY IH INC. 07392532291616

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention