BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S ATLANTIS ABUTMENT TI

    MDR report key: 17439400 · Received August 1, 2023

    Report

    Report Number
    1222802-2023-00015
    Event Type
    Injury
    Date Received
    August 1, 2023
    Report Date
    August 1, 2023
    Manufacturer
    DENTSPLY IH INC.
    Product Code
    NHA
    UDI-DI
    07392532083433
    PMA / PMN Number
    MULTIPLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 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 IMPLANT LOSS. SALES REP REPORTING FOR DOCTOR OFFICE THAT ABUTMENT FRACTURED AT THE HEX, AS A RESULT THE IMPLANT FRACTURED THE FRACTURED IMPLANT REPLACED WITH NEW EV IMPLANT. AS PER X-RAYS AND OTHER DOCUMENTATION NO FRACTURE OF THE IMPLANT IS VISIBLE. NO INFORMATION REGARDING WHERE ABOUT OF THE IMPLANT. HENCE THIS CASE WILL BE CLASSIFIED AS AN IMPLANT FRACTURE WITH IMPLANT REMOVAL IN CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481126 S ATLANTIS ABUTMENT TI ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA DENTSPLY IH INC. 07392532083433

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 29472 IMPLANT OSSEOSPEED TX 5.0 S X 11