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

Model Number	NBTYE TRAY
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
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
While using a byte night aligners, patient reported that they were evaluated by their dentist.The dentist evaluation findings: the patient was seen for chief complaint being that after several months with their byte aligners, their back teeth do not touch, and they are having difficulty chewing food.Upon analysis of her itero intraoral scan of the patient's teeth and bite, there is a heavy anterior contacts on teeth #23 and 24 with tooth #9 as well as tooth #7 with #26 and either no posterior contacts or very light posterior contact compared to the contralateral sided on teeth # 2, 3 and 4.It is recommended that the patient discontinue their aligner treatment with byte due to bite changes that are causing concern for chewing food properly and history of diverticulitis, which could flare up without proper mastication.It is recommended they start aligner treatment with an orthodontist who can more closely manage her case and add attachments, plan interproximal reduction and wear elastics as needed to eliminate heavy anterior contacts which could cause trauma to front teeth long term and so we can properly move their back molars into a more ideal biting position.
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.; york, PA 17401 ; 7178494593
• MDR Report Key: 20214834
• Report Number: 3014845255-2024-01032
• Device Sequence Number: 11822940
• 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): 10/09/2025

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: 08/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/09/2025
• 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