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

Model Number 8131

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Inflammation (1932)

Event Date 02/10/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 309880621
• Report Number: 3023370823-2023-00002
• Device Sequence Number: 1
• Product Code: DZC
• UDI-Device Identifier: 00850018135122
• UDI-Public: (01)00850018135122(10)WO145136(11)221207
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 8131
• Device Catalogue Number: 8131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2022
• 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: 35 YR
• Patient Sex: Female