BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S ATLANTIS ABUTMENT TI

    MDR report key: 20024692 · Received August 22, 2024

    Report

    Report Number
    1222802-2024-00011
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    June 21, 2024
    Report Date
    August 20, 2024
    Manufacturer
    DENTSPLY IH INC.
    Product Code
    NHA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. TREND IS TRACKED AND MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ABUTMENT SCREW FRACTURED INTO MULTIPLE PIECES WHILE HAND TIGHTENING. THE SCREW FRAGMENTS WERE UNABLE TO REMOVED AND THE IMPLANT NEEDS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117310 S ATLANTIS ABUTMENT TI ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA DENTSPLY IH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention COMPETITOR IMPLANT STRAUMANN BONE LEVEL 4.1, 4.8.