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	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The clinician confirmed that the surgical guide was cold sterilized prior to use, cold sterilization is a violation of vulcan custom dental's ifu as it could cause the sleeves to de-bond from the guide.A review of the surgical report and drilling protocol indicate the case was properly planned.
Event or Problem Description
Utilizing surgical guide print003, the clinician reported the guide sleeve for site #8 came out on the first pass of the tissue punch.Clinician attempted to place guide sleeve back in at the correct orientation but was unsuccessful, so drilling path was off, creating a loose osteotomy.There was no insertion torque for the implant, so the implant was removed, patient was grafted and sent home.

• 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 ; 8444842301
• MDR Report Key: 22162613
• Report Number: 3012481042-2025-00052
• Device Sequence Number: 21003368
• Product Code: NDP
• UDI-Device Identifier: 00810033850066
• UDI-Public: 00810033850066
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PRINT003
• Device Lot Number: CN366467
• 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: 05/30/2025
• Initial Report FDA Received Date: 06/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2025
• 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 Age: 30 YR
• Patient Sex: Unknown