BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESS DENTAL

    MDR report key: 24700212 · Received March 26, 2026

    Report

    Report Number
    2411236-2026-00002
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    March 2, 2026
    Report Date
    March 26, 2026
    Manufacturer
    TERRATS MEDICAL S.L.
    Product Code
    NHA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS REPORT RELATES TO REPORT NUMBER 1836016-2026-00001. A MALE PATIENT UNDERWENT A ROUTINE DENTAL CLEANING DURING WHICH THE CROWN AND ASSOCIATED IMPLANT COMPONENTS AT TOOTH #18 WERE STABLE, AND NO LOOSENING WAS NOTED. SEVERAL DAYS LATER AFTER THE PROCEDURE THE PATIENT RETURNED WITH THE CROWN SEPARATED FROM THE IMPLANT. CLINICAL ASSESSMENT INDICATED THAT THE ABUTMENT SCREW HAD FRACTURED INTO TWO PIECES, WITH THE APICAL PORTION REMAINING EMBEDDED IN THE IMPLANT. THE PATIENT WAS REFERRED TO AN ORAL SURGEON FOR REMOVAL OF THE RETAINED SCREW FRAGMENT USING SPECIALIZED INSTRUMENTATION. NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757969 DESS DENTAL TIBASE ENG STRBLX WB 0.8MM NHA TERRATS MEDICAL S.L.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention