MAUDE Adverse Event Report: Vulcan Custom Dental Vulcan Custom Dental Surgical Guide

Model 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	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Utilizing surgical guide, print003, doctor attempted placing implant in site 18, but noticed afer placement the implant was loose and had to be backed out.Patient was grafted and sent home.
Additional Manufacturer Narrative
A review of the surgical report and drilling protocol indicate the case was properly planned.The doctor stated that he believed the fault was with planning in that it "should have used a 5.2 instead of 4.6".The doctor did review and approve the surgical plan which utilized a 4.6mm implant.The implant the doctor received from vulcan custom denal was verified as the correct size ordered (4.6mm); surgical guide was requested for evaluation, but was not returned.

• 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 ; +1(205)484-2312
• MDR Report Key: 50853375
• Report Number: 3012481042-2026-00061
• Device Sequence Number: 21209320
• Product Code: NDP
• UDI-Device Identifier: 00810033850066
• UDI-Public: 00810033850066
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/21/2026

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 Model Number: PRINT003
• Device Lot Number: CN486676
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2026
• 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