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

Model Number PRINT003

Device Problem Use of Device Problem (1670)

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

Event Date 05/11/2023

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Utilizing dental surgical guide print003, dr.Claims implant "bottomed out" halfway into placement so doctor backed out the impant, grafted the site and sent patient home.

• Brand Name: VULCAN CUSTOM DERNTAL 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 ; 8444842301
• MDR Report Key: 16991683
• MDR Text Key: 315831809
• Report Number: 3012481042-2023-00026
• 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: 05/15/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2013
• 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