BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3DDX SURGICAL GUIDE

    MDR report key: 25111370 · Received May 7, 2026

    Report

    Report Number
    3011429437-2026-00004
    Event Type
    Injury
    Date Received
    May 7, 2026
    Manufacturer
    3D DIAGNOSTIX INC.
    Product Code
    NDP
    UDI-DI
    00850073333020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BOTH IMPLANTS HAVE FAILED A MONTH AFTER PLACEMENT, AFTER REVIEWING THE MOST RECENT SCANS TAKEN YESTERDAY, IMPLANT #22 SITE HAD A VERY BIG DEFECT WHICH THE DOCTOR CLEANED AND GRAFTED AFTER TAKING THIS SCAN. WHILE IMPLANT #27 APPEARS TO BE IN THE RIGHT POSITION BUT GOT AVULSED 2.5MM MORE CORONAL TO THE PLANNED POSITION AND IT HAS BONE LOSS ALL AROUND IT. AFTER DISCUSSION ITS WAS AGREED THAT THE FAILURE IS PROBABLY NOT RELATED TO HEAT NECROSIS, BUT TO THE PATIENT'S HEALING CAPACITY, AS PATIENT IS DIABETIC, AND ,ALSO ADVISED HIM TO DO A VITAMIN D INVESTIGATION.

    Description of Event or Problem · 0

    TWO IMPLANTS HAVE FAILED A MONTH AFTER PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328841 3DDX SURGICAL GUIDE DENTAL IMPLANT SURGICAL GUIDE NDP 3D DIAGNOSTIX INC. 634788 00850073333020

    Patients

    Seq Age Sex Outcome Treatment
    1