BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S ATLANTIS ABUTMENT TI

    MDR report key: 20014631 · Received August 21, 2024

    Report

    Report Number
    1222802-2024-00010
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    February 14, 2024
    Report Date
    August 16, 2024
    Manufacturer
    DENTSPLY IH INC.
    Product Code
    NHA
    UDI-DI
    07392532083433
    PMA / PMN Number
    MULTIPLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. SECTION H6 WAS DONE BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER AND OUR LONG-TIME EXPERIENCE AND THE INVESTIGATION OF THE PRODUCT AND SIMILAR COMPLAINTS. TREND IS TRACKED AND MONITORED.

    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
    1044213 S ATLANTIS ABUTMENT TI ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA DENTSPLY IH INC. 7872643 07392532083433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention