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

Model Number 85000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tooth Fracture (2428)

Event Date 11/07/2022

Event Type  Injury  

Manufacturer Narrative

Based on the input from the orthodontist's office, the bracket debonded while dental assistant was disengaging the smartwire from the bracket.She used an ingager instrument and applied a mediocre amount of pressure and proper technique.Debonded bracket was replaced and re-bonded on the spot as the issue occured while changing smartwires between regular visits.No further evaluation was possible.No bracket malfuntion was found.

Event Description

It was reported that during removal of the lower smartwire for a routine wire change, the bracket on the lower right 5 premolar tooth debonded.The bracket contained an adhesive and a small amount of tooth structure which appeared to be tooth enamel.

• 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: 15902395
• MDR Text Key: 304682195
• Report Number: 3013023655-2022-00005
• Device Sequence Number: 1
• Product Code: EJF
• UDI-Device Identifier: 00850018135047
• UDI-Public: (01)00850018135047(10)WO134332(11)220520
• 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: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• 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
• Device Lot Number: WO134332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2022
• 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: 52 YR
• Patient Sex: Female