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

Model Number PRINT004

Device Problem Use of Device Problem (1670)

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

Event Date 08/05/2022

Event Type  malfunction  

Event Description

Utilizing vulcan progressive line surgical guide, print004, implant was not placed to depth and was supracrestal by 3mm.Implant was backed out and the procedure was completed freehand utilizing different tools than specified in the drilling protocol.

Manufacturer Narrative

Case was properly planned per the drilling protocol and surgical report and correct parts were sent with the case so the only explanation to account for the unexpected result is a misuse of the guide, either the guide was not fully seated or the incorrect driver or stop position may have bee used during the procedure.

• 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: 15386682
• MDR Text Key: 303653980
• Report Number: 3012481042-2022-00021
• 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: 08/25/2022

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: PRINT004
• Device Catalogue Number: PRINT004
• Device Lot Number: CN167314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• 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
• Patient Sex: Prefer Not To Disclose