MAUDE Adverse Event Report: STRAIGHT SMILE, LLC BYTE NIGHT ALIGNERS; ALIGNER, SEQUENTIAL

Model Number	NBYTE TRAY
Medical Device Problem Codes	Unintended Movement (3026); Lack of Effect (4065)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.
Event or Problem Description
Patient reports dentist examination trigger by the safety notice revealed byte is contraindicated due to tooth occlusion requiring surgical correction.
Additional Manufacturer Narrative
A dhr review was conducted with no discrepancies noted.

• Brand Name: BYTE NIGHT ALIGNERS
• Common Device Name: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): STRAIGHT SMILE, LLC; 1556 20th st. , suite a; santa monica CA 90404
• Manufacturer (Section G): STRAIGHT SMILE, LLC; 1556 20th st. , suite a; santa monica CA 90404
• Manufacturer Contact: dan eagar ; 221 west philadelphia st; ste 60 w; york, PA 17401 ; 7178494593
• MDR Report Key: 21048966
• Report Number: 3014845255-2024-05411
• Device Sequence Number: 19685481
• Product Code: NXC
• UDI-Device Identifier: 00850017524170
• UDI-Public: 00850017524170
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2025

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 Model Number: NBYTE TRAY
• Device Catalogue Number: PRS-0063
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown