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

Model Number 8130

Device Problem Migration (4003)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

The patient had her final wires placed a few weeks before the orthodontist noticed that the lower interdental loop of the wire was deeply embedded into the gingiva.The issue was most likely related to the wire interdental loops being too close to the gingiva.

Event Description

Patient experienced a large amount of wire deeply embedded into the lingual gingiva between the lower left 3-4 tooth.The orthodontist tried to release the wire by pulling it through the gingiva, then with a scalpel by making small incisions.Ultimately, the wire was cut and removed.

• Brand Name: INBRACE
• 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
• MDR Report Key: 11899032
• MDR Text Key: 266280997
• Report Number: 3013023655-2021-00003
• 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: 05/27/2021

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: 8130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 05/27/2021
• 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: 13 YR