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 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

A review of the drilling protocol and surgical report indicate the case was properly planned and no defects were noted on the returned surgical guide.In addition, a radiograph taken after the implant was placed, was was sent to dr.Cleber silva for review and per dr.Silva, the radiograph sent to him by the doctor shows the implant appears to have been placed as planned, he also stated that "immediate implants usually go at an angle to engage native bone but this implant was straight as it had at least 5.0 mm of post-apical bone engagement.".

Event Description

Utilizing dental surgical guide print003, clinician states that they could not initially get the implant to engage with bone and after it was engaged, the clinician felt the placement was off, so implant was removed, patient was grafted and 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: 19169135
• MDR Text Key: 341417166
• Report Number: 3012481042-2024-00032
• 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: 03/26/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2024
• 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