MAUDE Adverse Event Report: BRIUS BRIUS

Model Number 100

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/13/2022

Event Type  Injury  

Manufacturer Narrative

After initially noting the extreme movement in ur2, but not understanding the cause, the doctor ordered a replacement as opposed to taking a new ct scan and ordering a refinement;the original device was replaced.In a replacement, an identical device is manufactured using the same mold as used to shape form the original device.As the tooth continued its unusual movement, the doctor removed the replacement device and submitted a new ct scan and ordered a refinement on (b)(6) 2022.When a refinement is ordered, a new ct scan must be submitted.A new mold must be created as a refinement indicates a change in the treatment plan.Therefore, new molds were created to shape form the refinement device and the tooth movement was corrected.The refinement was shipped on (b)(6) 2022.Upon receipt of the refinement, the doctor returned both the original and replacement devices (524585.00bb, and 524585.01bn) to brius for review on (b)(6) 2022.An investigation was performed on the returned devices.After comparing the intended design of the brius to the actual device, it was noticed that the positioning of the arm to the tooth in question was different than intended.After examination of the mold used for shape forming, it was determined that the mold had been damaged causing the arm for ur2 to have a slight unintended bend.The unintentional bend caused some of the unintended movement of ur2, but the problem was compounded by bracket positioning error when the bracket for ur2 was not bonded to the patient in the correct intended position.The patient has received a new device and is doing well.

Event Description

Tooth upper right 2 ur@ is very mobile.Patient is uncomfortable and afraid she may lose tooth.Evaluated bracket position and determined one of two things causing tooth to be tipped lingually and supererupted; 1- issue with brius design itself (ur2 arm is significantly more lingual and incisal.

• Brand Name: BRIUS
• Type of Device: BRIUS
• Manufacturer (Section D): BRIUS; 2661 westgrove dr. #109,; carrollton TX 75006
• Manufacturer (Section G): BRIUS; 2661 westgrove dr. #109; carrollton TX 75006
• Manufacturer Contact: michael gregory ; 2661 westgrove dr. #109; carrollton, TX 75006 ; 9039754230
• MDR Report Key: 14269183
• MDR Text Key: 291974228
• Report Number: 3014680924-2022-00002
• 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: 04/29/2022

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: 100
• Device Lot Number: 524585.00BB;524585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2022
• Initial Date FDA Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• 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): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White