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

Model Number 85004

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/05/2023

Event Type  Injury  

Manufacturer Narrative

The patient had her smartwires placed a few weeks before the orthodontist noticed that the gingival papilla got inflamed causing swelling and covering of the upper smartwire interproximal loop between the upper central incisors.According to the orthodontist, this type of inflammation is frequently seen in orthodontic patients who do not practice good oral hygiene such as regular flossing and bushing.Proper oral hygiene instructions were provided to the patient including manual and water flossing.

Event Description

Patient experienced tissue inflammation and an interproximal loop of the upper smartwire embedded in the gingival papilla between the upper central incisors.The smartwire was sectioned and removed to allow the papilla to heal.

• Brand Name: INBRACE TOOTH STRAIGHTENING SYSTEM (GEN 2.0)
• Type of Device: ORTHODONTIC APPLIANCE
• Manufacturer (Section D): SWIFT HEALTH SYSTEMS, INC.; irvine CA
• Manufacturer Contact: alicia mszyca ; 5 goodyear; irvine, CA 92618 ; 9497742239
• MDR Report Key: 16261770
• MDR Text Key: 308345826
• Report Number: 3023370823-2023-00001
• Device Sequence Number: 1
• Product Code: DZC
• 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: 01/29/2023

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
• Device Operator: Health Professional
• Device Model Number: 85004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 01/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2022
• 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: 30 YR
• Patient Sex: Female