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

Health Effect - Clinical Codes	Pain (1994); Deformity/ Disfigurement (2360); Physical Asymmetry (4573)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
I began treatment with byte aligners on (b)(6) 2023.I used the product as instructed and wore the retainers for approximately a year.Over time, i developed painful and harmful side effects, including clashing of my front teeth, loss of contact between my back teeth, and bite misalignment.I reported these issues to byte multiple times.Instead of properly evaluating the situation, they sent me additional aligners that worsened my bite and advised me to continue, claiming my bite would improve over time.Eventually, the discomfort and misalignment became so severe that i had to stop wearing the retainers altogether.Recently, byte issued an urgent field safety notification admitting their treatment onboarding may not adequately screen for conditions like mine, which could result in exactly the kinds of complications i've experienced.Despite this acknowledgment, byte has refused to address my concerns, denied me a refund, and will no longer assist me in any way.

• Brand Name: BYTE TEETH ALIGNERS
• Common Device Name: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): STRAIGHT SMILE, LLC
• MDR Report Key: 21962027
• Report Number: MW5169957
• Device Sequence Number: 7272593
• Product Code: NXC
• Combination Product (Y/N): N
• Initial Reporter Country: PR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White