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

Model Number PRINT003

Device Problem Installation-Related Problem (2965)

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

Event Date 11/02/2021

Event Type  malfunction  

Event Description

Prior to procedure, the master cylinder popped out of the surgical guide and went into suction resulting in the doctor not being able to perform the procedure utilizing the surgical guide.No drilling was performed utilizing the guide but site was tissue punched just prior to the master cylinder popping out.

Manufacturer Narrative

A review of the surgical report and internal work ticket revealed the incorrect master cylinder/guide sleeve was used in the assembly of the surgical guide which resulted in the issue with the master cylinder.

• Brand Name: VULCAN CUSTOM DENTAL 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: brett muetzel ; 2300 riverchase center; suite 825; birmingham, AL 35244 ; 2054842312
• MDR Report Key: 12828041
• MDR Text Key: 282045045
• Report Number: 3012481042-2021-00013
• 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: 11/09/2021

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
• Device Lot Number: CN100977
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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