BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3DDX SURGICAL GUIDE

    MDR report key: 25111315 · Received May 7, 2026

    Report

    Report Number
    3011429437-2026-00003
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    January 15, 2026
    Report Date
    April 28, 2026
    Manufacturer
    3D DIAGNOSTIX INC.
    Product Code
    NDP
    UDI-DI
    00850073333020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CASE WAS PROPERLY PLANNED AND AN EXPLANATION TO THE DOCTOR THAT IT WAS ALREADY CONFIRMED BEFORE PROCEEDING, AND ONLY PROCEEDED UPON THE DOCTOR'S APPROVAL. THE ISSUE WAS DUE TO NON-RELIABLE INPUT DATA.

    Description of Event or Problem · 0

    THE GUIDE DID NOT POSITION THE IMPLANT IN BONE 1/2 OFF THE PILOT DRILL WAS LINGUAL TO THE BONE. THERE WAS A 5 MM WIDTH OF BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502847 3DDX SURGICAL GUIDE DENTAL IMPLANT SURGICAL GUIDE NDP 3D DIAGNOSTIX INC. 622216 00850073333020

    Patients

    Seq Age Sex Outcome Treatment
    1