MAUDE Adverse Event Report: 3D DIAGNOSTIX INC. 3DDX SURGICAL GUIDE; DENTAL IMPLANT SURGICAL GUIDE

Lot Number	622216
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: 3DDX SURGICAL GUIDE
• Common Device Name: DENTAL IMPLANT SURGICAL GUIDE
• Manufacturer (Section D): 3D DIAGNOSTIX INC.; 24 denby rd; suite 148; allston MA 02134
• Manufacturer (Section G): 3D DIAGNOSTIX INC.; 24 denby rd; suite 148; allston MA 02134
• Manufacturer Contact: ehab amin ; 24 denby rd; suite 148; allston, MA 02134
• MDR Report Key: 25111315
• Report Number: 3011429437-2026-00003
• Device Sequence Number: 21394695
• Product Code: NDP
• UDI-Device Identifier: 00850073333020
• UDI-Public: 00850073333020
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 622216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown