BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3DDX SURGICAL GUIDE

    MDR report key: 24626529 · Received March 18, 2026

    Report

    Report Number
    3011429437-2026-00001
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    January 8, 2026
    Report Date
    March 18, 2026
    Manufacturer
    3D DIAGNOSTIX INC.
    Product Code
    NDP
    UDI-DI
    00850073333020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803.THE DHR REVIEW AND THE INVESTIGATION OF THE DIGITAL DESIGN FILE DID NOT REVEAL ANOMALIES. NO RETURNED MATERIAL.

    Description of Event or Problem · 0

    THE IMPLANT ON SITE #12 WAS VERY CLOSE TO ADJACENT TOOTH AND HAD TO BE REMOVED AND GRAFTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688822 3DDX SURGICAL GUIDE DENTAL IMPLANT SURGICAL GUIDE NDP 3D DIAGNOSTIX INC. 621416 00850073333020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention