BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ABUTMENT ZR 00

    MDR report key: 25223875 · Received May 19, 2026

    Report

    Report Number
    1222802-2026-00016
    Event Type
    Injury
    Date Received
    May 19, 2026
    Report Date
    May 19, 2026
    Manufacturer
    DENTSPLY IH INC.
    Product Code
    NHA
    UDI-DI
    07392532083426
    PMA / PMN Number
    MULTIPLE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DENTSPLY SIRONA BECAME AWARE OF A MALFUNCTION FOR SAME/SIMILAR DEVICES THAT COULD HAVE POSSIBLY CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. PRODUCT RETURN IS REQUESTED AND 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 DENTAL IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7991 ATLANTIS ABUTMENT ZR 00 ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA DENTSPLY IH INC. 07392532083426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention