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

Model Number 85000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Tooth Fracture (2428)

Event Date 11/08/2022

Event Type  Injury  

Manufacturer Narrative

No device malfunction has been found.Treatment instructions provided with the device informed of expected collisions between upper and lower teeth and recommended the use of bite turbos to avoid occlusal interference between brackets and teeth.

Event Description

It was alleged that the patient's tooth (lower first biocuspid) chipped due to interference with the upper bracket placed too incisally.The patient had her upper inbrace appliance removed and decided not to return to it.The patient was switched to upper aligners instead to complete the treatment.

• Brand Name: INBRACE TEETH STRAIGTHENING SYSTEM (GEN 2.0)
• Type of Device: ORTHODONTIC APPLIANCE
• Manufacturer (Section D): SWIFT HEALTH SYSTEMS; 111 academy, suite 150; irvine CA 92617
• Manufacturer Contact: alicia mszyca ; 111 academy; suite 150; irvine, CA 92617 ; 9497742239
• MDR Report Key: 15848814
• MDR Text Key: 304176014
• Report Number: 3013023655-2022-00003
• Device Sequence Number: 1
• Product Code: EJF
• 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: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2022
• 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): Other
• Patient Age: 28 YR
• Patient Sex: Female