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

Model Number	85003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	11/07/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that during removal of the lower smartwire for a routine wire change, the bracket on the lower left 4 premolar tooth debonded.The bracket contained an adhesive and a small amount tooth structure which appeared to be tooth enamel.

• Brand Name: INBRACE TEETH STRAIGTHENING SYSTEM (GEN 2.0)
• Common Device Name: 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: 15902376
• Report Number: 3013023655-2022-00004
• Device Sequence Number: 12030053
• Product Code: EJF
• UDI-Device Identifier: 00850018135054
• UDI-Public: (01)00850018135054(10)WO133030(11)220428
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K203442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/01/2022

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
• Operator of Device: Health Professional
• Device Model Number: 85003
• Device Catalogue Number: 85003
• Device Lot Number: WO133030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female