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

Model Number 85000

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/01/2022

Event Type  Injury  

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 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)
• Type of Device: 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
• MDR Text Key: 303294898
• Report Number: 3013023655-2022-00002
• Device Sequence Number: 1
• Product Code: DZC
• UDI-Device Identifier: 00850018135047
• UDI-Public: (01)00850018135047(10)WO135959(11)220623
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203442
• 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: 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
• Device Operator: Health Professional
• Device Model Number: 85000
• Device Catalogue Number: 85000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2022
• 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: 29 YR
• Patient Sex: Female