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

Lot Number	631719
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the surgical guide case indicate taht it was an error during the guide's sleeving process.
Event or Problem Description
Doctor mentioned that the guide did not stop her for the pilot site and went way deeper than planned.

• Brand Name: 3DDX DENTAL 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 ; 8668347925
• MDR Report Key: 25111332
• Report Number: 3011429437-2026-00002
• Device Sequence Number: 16040974
• 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): 04/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 631719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2026
• 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
• Patient Sex: Unknown