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

Model Number	NBTYE TRAY
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Type of Reportable Event	Serious Injury
Event or Problem Description
While using a byte night aligners, patient reported a front lower tooth came lose when they removed the aligner.They had an emergency dental visit with their dentist who told them that the aligners are not moving their teeth properly, if they continue using the byte aligners they will lose their tooth.Lor from dentist confirming mobility on #24 and #25, advising patient to cease aligner treatment and to seek treatment from an orthodontist.
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.
Additional Manufacturer Narrative
A dhr review was conducted with no discrepancies noted.

• Brand Name: BYTE NIGHT ALIGNER
• 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 w. philadelphia st.; ste 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 20329536
• Report Number: 3014845255-2024-01283
• Device Sequence Number: 7991830
• 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): 10/08/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: NBTYE TRAY
• Device Catalogue Number: PRS-0063
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2024
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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: Required Intervention
• Patient Sex: Unknown