MAUDE Adverse Event Report: SWIFT HEALTH SYSTEMS, INC. INBRACE TEETH STRAIGTHENING SYSTEM ( GEN 2.0); ORTHODONTIC APPLIANCE

Model Number	85000
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient had her initial wires placed a few months before the orthodontist noticed that the upper wire was embedded into the anterior gingiva.No progress records were provided to determine if the issue was an oral hygiene problem.No wire defect was identifed.
Event or Problem Description
Patient experienced an orthodontic wire embedded into the lingual gingiva, between the upper anterior tooth # 8 and # 9.The wire was cut into sections and each section removed by pulling through the gingiva.The patient was instructed to rinse the mouth with warm salt water and alow 4-5 weeks to heal the tissue prior to insertion of a new wire.

• Brand Name: INBRACE TEETH STRAIGTHENING SYSTEM ( GEN 2.0)
• Common Device Name: ORTHODONTIC APPLIANCE
• Manufacturer (Section D): SWIFT HEALTH SYSTEMS, INC.; 111 academy, suite 150; irvine CA 92617
• Manufacturer Contact: alicia mszyca ; 111 academy; suite 150; irvine, CA 92617 ; 9497742239
• MDR Report Key: 15756633
• Report Number: 3013023655-2022-00002
• Device Sequence Number: 15122114
• Product Code: DZC
• UDI-Device Identifier: 00850018135047
• UDI-Public: (01)00850018135047(10)WO135959(11)220623
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/07/2022

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
• Operator of Device: Health Professional
• Device Model Number: 85000
• Device Catalogue Number: 85000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2022
• 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: 29 YR
• Patient Sex: Female