BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S ATLANTIS ABUTM GOLDSHADED TI

    MDR report key: 19613674 · Received June 26, 2024

    Report

    Report Number
    1222802-2024-00008
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    June 19, 2024
    Report Date
    June 26, 2024
    Manufacturer
    DENTSPLY IH INC.
    Product Code
    NHA
    UDI-DI
    07392532083440
    PMA / PMN Number
    MULTIPLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    SCREW BROKE. ANKYLOS IMPLANT MAY NEED TO BE TREPHINED OUT. DOCTOR HAS ORDERED TREPHINE DRILL TO REMOVE IMPLANT. IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626249 S ATLANTIS ABUTM GOLDSHADED TI ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA DENTSPLY IH INC. 1156024 07392532083440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention UNKNOWN ANKYLOS IMPLANT