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	04/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Utilizing surgical guide print 003, final implant placement in location #7 deviated from plan and terminated in the cortical plate.
Additional Manufacturer Narrative
An inspection of the returned surgical guide revealed no defects with materials or components, guide placement and fit on a printed model was accurate and secure; a review of the surgical report and drilling protocol indicate the case was properly planned.Planning clinician also evaluated the case and provided the following feedback: "we rechecked the case and digitally everything seems to be in order even though the cbct scan is a bit hazy due to the metal restorative work and slight motion haziness which might have affected the accuracy to a point.Medio-distal placement is consistent with the planning, it seems that the drilling trajectory was slightly more buccal than planned leading to the apex of the implant in very close contact with the buccal plate, however, the original planning had the implant slightly tilted towards the buccal plate to avoid the nuitrient canal in the site and to maintain a screw retained emergence.Other factors that might affect the drilling path could be that the guide was slightly tilted during seating.Review of the post grafting scans shows that bone coverage is suffiecient and follow-up is recommended to ensure graft integration.The most probable cause would be a mixture of the above factors (slight haziness in the cbct scan affecting guide accuracy and having the implant's apex planned close to the buccal plate due to the above reasons).".

• 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: 25142482
• Report Number: 3012481042-2026-00060
• Device Sequence Number: 15784140
• 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): 05/11/2026

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: CN448134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2026
• 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