BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3DDX DENTAL SURGICAL GUIDE

    MDR report key: 25111332 · Received May 7, 2026

    Report

    Report Number
    3011429437-2026-00002
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    February 25, 2026
    Report Date
    April 7, 2026
    Manufacturer
    3D DIAGNOSTIX INC.
    Product Code
    NDP
    UDI-DI
    00850073333020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SURGICAL GUIDE CASE INDICATE TAHT IT WAS AN ERROR DURING THE GUIDE'S SLEEVING PROCESS.

    Description of Event or Problem · 0

    DOCTOR MENTIONED THAT THE GUIDE DID NOT STOP HER FOR THE PILOT SITE AND WENT WAY DEEPER THAN PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347619 3DDX DENTAL SURGICAL GUIDE DENTAL IMPLANT SURGICAL GUIDE NDP 3D DIAGNOSTIX INC. 631719 00850073333020

    Patients

    Seq Age Sex Outcome Treatment
    1