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

Lot Number	646616
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The doctor reflected a flap and the guide was well seated, he checks it visually through the inspection windows (didn't use a probe to check for gaps).A review of the the post-op scans indicate the implant was placed at a completely different position than planned, hitting the root of the adjacent incisor and perforating the lingual plate (which should be felt clinically due to high resistance of the cortical bone).The guide must have been seated improperly or the drills must have been inserted in the wrong direction to end up with such a huge discrepancy.
Event or Problem Description
The implant position was too close to the #23 and it perforated lingual plate.

• 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: 25751648
• Report Number: 3011429437-2026-00007
• Device Sequence Number: 10242861
• 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): 07/08/2026

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?: No
• Device Lot Number: 646616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown