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

Catalog Number	PRS-0063
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); 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 reported their dentist has confirmed that the aligner treatment was not appropriate for their dental condition.The treatment has caused clear damage to their dental structure.At check in patient marked true to discomfort, pain level 10, excessive bleeding, periodontitis, infection, allergic reaction, inflammation, blisters, gingivitis, sensitivity, not fitting, jaw discomfort, chipped.
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; 3301 n thanksgiving way; lehi UT 84043
• Manufacturer (Section G): STRAIGHT SMILE LLC; 3301 n thanksgiving way; lehi UT 84043
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 22467576
• Report Number: 3031789024-2025-03121
• Device Sequence Number: 8528262
• Product Code: NXC
• UDI-Device Identifier: 00850017524170
• UDI-Public: 00850017524170
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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 Catalogue Number: PRS-0063
• Device Lot Number: SN3981LASD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/22/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2021
• 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; Disability
• Patient Sex: Unknown