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

Lot Number	634788
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Two implants have failed a month after placement.

• 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: 25111370
• Report Number: 3011429437-2026-00004
• Device Sequence Number: 13332116
• 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

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: 634788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown