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

Model Number PRINT003

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 11/23/2021

Event Type  malfunction  

Event Description

Utilizing surgical guide print003, dr.Stated that implant at #6 location was touching #5 when fully placed.Osteotomy entry was too distal for the space but trusted guide and proceeded.Had to back out the implant, pack bone and send the patient home for healing.

Manufacturer Narrative

Case was planned with scans almost 7 months old.Usually, the scans have an expiration of only 6 months meaning timing could be an issue.If the guide was not fully seated, that could very well be the reason for the misplacement.Also, the xray the dr took after the placement is only a 2d xray.This has occurred for other dr's where the xray beam is not directed to the center of the implant and this angulation may cause the "malposition" of the implant.The dr.May want to rescan the patient centering the xray beam at the center of the implant for a better view of the actual position.

Manufacturer Narrative

Case was planned with scans almost 7 months old.Usually, the scans have an expiration of only 6 months meaning timing could be an issue.If the guide was not fully seated, that could very well be the reason for the misplacement.Also, the xray the dr took after the placement is only a 2d xray.This has occurred for other dr's where the xray beam is not directed to the center of the implant and this angulation may cause the "malposition" of the implant.The dr.May want to rescan the patient centering the xray beam at the center of the implant for a better view of the actual position.

Event Description

Utilizing surgical guide print003, dr.Stated that implant at #6 location was touching #5 when fully placed.Osteotomy entry was too distal for the space but trusted guide and proceeded.Had to back out the implant, pack bone and send the patient home for healing.

• 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 ; 8444842301
• MDR Report Key: 12990551
• MDR Text Key: 285486729
• Report Number: 3012481042-2021-00016
• 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: 12/03/2021

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: CN100514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/13/2021
• 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