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

Model Number	PRINT 003
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the surgical report and drilling protocol indicate the case was properly planned and there were no recommendations or concerns that the site was insufficient.Prior to the procedure it was noted by the planning clinician that the site had healed without evidence of an extraction socket, bone density was excellent (d3, d2, d1) and the implant was planned to be completely surrounded by bone.  there was no expectation of failure other than the inherent possibility of 3 to 4% of implant failing for unknown reasons.
Event or Problem Description
Utilizing surgical guide print 003, the implant at location 22 did not take in the bone and had to be backed out of the implant site.Patient left with plug at site and no implant.

• 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: 21317425
• Report Number: 3012481042-2025-00045
• Device Sequence Number: 15562974
• Product Code: NDP
• UDI-Device Identifier: 00810033850066
• UDI-Public: 00810033850066
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 02/05/2025

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: PRINT 003
• Device Lot Number: CN339763
• 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: 01/14/2025
• Initial Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2024
• 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: Prefer Not To Disclose