MAUDE Adverse Event Report: BRIUS BRIUS; ORTHODONTIC WIRE

Model Number 100

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

Patient Problem Skin Infection (4544)

Event Date 04/15/2022

Event Type  Injury  

Manufacturer Narrative

Brius conducted a review of the dhr and the treatment plan for the patient.There were no non-conformances or deviations found.It can be reasonably assumed that the arm connecting bar of the brius to the bracket on the tooth was either designed "too long," which allowed it embed in the tissue or the device arm was designed too close to the tissues.Because a new scan was sent, a new device was manufactured and sent to the patient's physician.At this time, it appears that the device has been replaced and no further issues have presented.

Event Description

Patient has been on 14 day antibiotics again for wire embedded into gums and causing an abscess.

• Brand Name: BRIUS
• Type of Device: ORTHODONTIC WIRE
• Manufacturer (Section D): BRIUS; 2611 westgrove drive; carrollton TX 75006
• Manufacturer Contact: micheal gregory ; 2611 westgrove drive; carrollton, TX 75006 ; 9039754230
• MDR Report Key: 14431754
• MDR Text Key: 291973953
• Report Number: 3014680924-2022-00003
• Device Sequence Number: 1
• Product Code: DZC
• UDI-Device Identifier: 0860002991009
• UDI-Public: (01)0860002991009(10)524971.11NB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/13/2022

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: 524971.11NB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2022
• Initial Date FDA Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• 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: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White