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

Model Number PRINT003

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2022

Event Type  malfunction  

Manufacturer Narrative

Event occurred (b)(6) 2022, but vulcan custom dental was not notified there was an issue with the procedure until 02/24/2023.A review of the surgical plan and drilling protocol indicate case was properly planned and the errant placement of the implant was very likely a result of the surgical guide not being fully seated.Vulcan custom dental requested the surgical guide from the doctor for evaluation, but were informed the doctor had disposed of the guide.

Event Description

Utilizing surgical guide, print 003, doctor drilled to depth and placed implant.When he finished and took the guide off, the doctor felt as though something wasn't right so he flapped the site and saw the implant was parallel to the buccal plate but 50% out of the bone.The doctor then backed out the implant and replaced it by hand and fully grafted the patient, closed the patient up and sent them home.

• Brand Name: VULCAN CUSTOM DENTAL SURGICAL GUIDE
• Type of Device: 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: 16500266
• MDR Text Key: 310864256
• Report Number: 3012481042-2023-00024
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/07/2023

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
• Device Operator: Health Professional
• Device Model Number: PRINT003
• Device Catalogue Number: PRINT003
• Device Lot Number: CN158501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2023
• Initial Date FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR