BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S ATLANTIS CUSTOMBASEGS/ZRCRFC

    MDR report key: 23682030 · Received December 1, 2025

    Report

    Report Number
    1222802-2025-00030
    Event Type
    Injury
    Date Received
    December 1, 2025
    Date of Event
    July 23, 2025
    Report Date
    December 1, 2025
    Manufacturer
    DENTSPLY IH INC.
    Product Code
    NHA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. SECTION H6 WAS DONE BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER AND OUR LONG-TIME EXPERIENCE IN THE INVESTIGATION OF SIMILAR COMPLAINTS. PRODUCT RETURN IS REQUESTED, AND PRODUCT 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 ABUTMENT FRACTURE AND A DENTAL IMPLANT FRACTURE. THE DENTAL IMPLANT WAS EXPLANTED AS A RESULT. THIS REPORT IS FOR THE DENTAL ABUTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2150453 S ATLANTIS CUSTOMBASEGS/ZRCRFC ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA DENTSPLY IH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention