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

Lot Number	621416
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The dhr review and the investigation of the digital design file did not reveal anomalies.No returned material.
Event or Problem Description
The implant on site #12 was very close to adjacent tooth and had to be removed and grafted.

• 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 ; 8668347925
• MDR Report Key: 24626529
• Report Number: 3011429437-2026-00001
• Device Sequence Number: 12910507
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

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: 621416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2025
• 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