MAUDE Adverse Event Report: VULCAN CUSTOM DENTAL VULCAN CUSTOM DENTAL SURGICAL GUIDE

Catalog Number	PRINT003
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Surgical guide was requested for evaluation but was not returned.Case was reviewed by the planning clinician and the following feedback provided: ".Due to the buccal inclination of both implants and given the good registration, result that the guide was slightly tilted while being seated mid surgery.".
Event or Problem Description
While utilizing surgical guide print003, implant placed in location #27 appears to have deviated from the plan's final placement, implant will be removed and patient grafted.

• Brand Name: VULCAN CUSTOM DENTAL SURGICAL GUIDE
• Common Device Name: DENTAL SURGICAL GUIDE
• Manufacturer (Section D): VULCAN CUSTOM DENTAL; 2300 riverchase center; suite 825; birmingham AL 35244
• Manufacturer (Section G): VULCAN CUSTOM DENTAL; 2300 riverchase center; suite 825; birmingham AL 35244
• Manufacturer Contact: brett muetzel ; 2300 riverchase center; suite 825; birmingham, AL 35244 ; 2054842312
• MDR Report Key: 25068843
• Report Number: 3012481042-2026-00059
• Device Sequence Number: 13446350
• Product Code: NDP
• UDI-Device Identifier: 00810033850066
• UDI-Public: 00810033850066
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/01/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: PRINT003
• Device Lot Number: CN441770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2026
• 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 Age: 30 YR
• Patient Sex: Unknown