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

Model Number PRINT003

Device Problems Unstable (1667); Unintended Movement (3026)

Patient Problem Perforation (2001)

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

The doctor felt that the repositioned implant was effective for his patient.

Event Description

The dentist used the vulcan custom dental surgical guide to prepare osteotomies within the patients mount in preparation for placing dental implants.The complaint was that the guide within site #7 was moving around and unstable.The doctor used the guide anyways and felt that the implant (once placed in the osteotomy) was too buccal for a good restoration.The surgical guide was removed.Then the implant was removed.Then the doctor re-placed the dental implant in a "free-hand" manner to achieve the angulation and positioning he felt was correct.

• Brand Name: VULCAN SURGICAL GUIDE
• Type of Device: DENTAL IMPLANT 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: craig estes ; 2300 riverchase center; birmingham, AL 35244 ; 8444842301
• MDR Report Key: 8972240
• MDR Text Key: 194344881
• Report Number: 3012481042-2019-19622
• 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
• Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/05/2019

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
• Device Operator: Health Professional
• Device Model Number: PRINT003
• Device Lot Number: CN046514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 09/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2019
• 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): Other
• Patient Age: 50 YR
• Patient Weight: 82