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

Model Number PRINT003

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 06/13/2022

Event Type  malfunction  

Event Description

Doctor states while utilizing surgical guide print003, implant was placed too close to neighboring root and as a result, implant was backed out, the site grafted and patient sent 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 ; 8444842301
• MDR Report Key: 15042283
• MDR Text Key: 304691789
• Report Number: 3012481042-2022-00019
• 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: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• 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: CN157813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2022
• 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