MAUDE Adverse Event Report: SWIFT HEALTH SYSTEMS, INC INBRACE; ORTHODONTIC APPLIANCE

Model Number 6500-11

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Glossitis (4490)

Event Date 07/30/2019

Event Type  Injury  

Manufacturer Narrative

Per the orthodontist's comment, the patient could not tolerate lingual orthodontic appliance and may or may not pursue a different orthodontic option.

Event Description

Patient was bonded on (b)(6) 2019 with the inbrace orthodontic appliance system.The patient was seen 4 days later to reclinch the end of the wire on the lower terminal teeth.The next day the patient returned to the office with significant ulcers on her tongue and she complained of a sore throat.The orthodontist prescribed an antibiotic and removed the appliance from the terminal teeth and clinched at the lower premolars (l6s).The following day the patient reported severe discomfort and requested removal of her braces.

• Brand Name: INBRACE
• Type of Device: ORTHODONTIC APPLIANCE
• Manufacturer (Section D): SWIFT HEALTH SYSTEMS, INC; 111 academy, suite 150; irvine 92617
• Manufacturer Contact: alicia mszyca ; 111 academy, suite 150; irvine 92617 ; 9497742239
• MDR Report Key: 11882513
• MDR Text Key: 252664222
• Report Number: 3013023655-2021-00002
• 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: 05/25/2021

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: 6500-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2019
• 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: 43 YR