MAUDE Adverse Event Report: SWIFT HEALTH SYSTEMS. INC. INBRACE TEETH STRAIGHTENING SYSTEM; ORTHODONTIC APPLIANCE

Model Number	8131
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient experienced a palatal swelling between the upper front teeth while wearing inbrace appliance system.The upper smartwire was cut, removed and replaced to finish the treatment.
Event or Problem Description
It was reported that the patient's upper smartwire was cut in half due a palatal swelling between the upper front teeth.The smartwire was pushing on the palate and had to be removed.The orthodontist removed the wire and requested a wire replacement.

• Brand Name: INBRACE TEETH STRAIGHTENING SYSTEM
• Common Device Name: ORTHODONTIC APPLIANCE
• Manufacturer (Section D): SWIFT HEALTH SYSTEMS. INC.; irvine CA
• Manufacturer (Section G): SWIFT HEALTH SYSTEMS, INC; 5 goodyear; irvine CA 92618
• Manufacturer Contact: alicia mszyca ; 5 goodyear; irvine, CA 92618 ; 9497742239
• MDR Report Key: 16406097
• Report Number: 3023370823-2023-00002
• Device Sequence Number: 11595051
• Product Code: DZC
• UDI-Device Identifier: 00850018135122
• UDI-Public: (01)00850018135122(10)WO145136(11)221207
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K203442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/20/2023

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
• Operator of Device: Health Professional
• Device Model Number: 8131
• Device Catalogue Number: 8131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female