MAUDE Adverse Event Report: BRIUS BRIUS; ORTHODONTIC APPLIANCE

Model Number BRIUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sensitivity of Teeth (2427)

Event Date 12/16/2021

Event Type  Injury  

Manufacturer Narrative

Brius appliances are custom made and design specifically for each patient.A treatment plan was created for this patient and approved by the treating physician.The device was manufactured on 10/27/2021.The patient was pregnant at the time of device installation.After delivery of the child, she returned to the physician because of tooth discoloration.The doctor submitted a request to have a new appliance manufactured for the patient and to reduce the force on that tooth by 50-60%.A new device was manufactured and shipped to the patient on 12/22/2021.To our knowledge, the new brius appliance was installed on the patient and is still in use without further incident.The treating physician was contacted could not confirm or deny that the brius appliance caused the tooth trauma.

Event Description

During our standard review of documentation in our system, we discovered a comment made by a treating dds.The dds asked for an adjustment to the brius device to reduce the force on one tooth because the tooth was "discolored".The exact text of the message was "tooth no.9 (ul1) is discolored.Please make the replacement brius with less force application (%50-%60) to ul1." as with any orthodontic wire, adjustments are made commonly.The note of tooth discoloration might indicate an interrupted blood supply to the tooth.This could be the result of high forces acting on the tooth and moving it too quickly, which could include past trauma or recent trauma to the tooth.The adjustment was made immediately.At a later unspecified time, the dds determined the tooth had a dead root and a routine root canal was performed on the tooth.This corrected the issue with no further reported issues.While the treating dds did not feel the brius device was the cause of this event, out of an abundance of caution, we are reporting the event under the mdr system.

• Brand Name: BRIUS
• Type of Device: ORTHODONTIC APPLIANCE
• Manufacturer (Section D): BRIUS; 2611 westgrove drive; carrollton TX 75006
• Manufacturer Contact: medhi peikar ; 2611 westgrove dr.; carrollton, TX 75006 ; 3214791449
• MDR Report Key: 13667730
• MDR Text Key: 290809810
• Report Number: 3014680924-2022-00001
• Device Sequence Number: 1
• Product Code: DZC
• 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
• Type of Report: Initial
• Report Date: 03/04/2022

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: BRIUS
• Device Catalogue Number: 100
• Device Lot Number: 524889.01BN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• 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): Other
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White