MAUDE Adverse Event Report: DENTSPLY SIRONA INC BYTE ALIGNERS; ALIGNER, SEQUENTIAL

Health Effect - Clinical Codes	Tooth Fracture (2428); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
I am reporting patient abandonment and lack of clinical oversight following the issuance of a field safety notice.Despite ongoing treatment with a prescription medical device (clear aligners), the prescribing physician, (b)(6), and byte support have failed to provide the mandated dental supervision.I have experienced tooth mobility, bite misalignment and crowding leading to chipping and need dental work.I have repeatedly contacted byte support to report these adverse experiences, but my concerns were ignored or not addressed.Following the recent field safety notice, the company has failed to provide a safe clinical exit strategy or a refund to seek corrective care from a local provider.The device lacks the professional monitoring required by law for a class ii medical device.

• Brand Name: BYTE ALIGNERS
• Common Device Name: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): DENTSPLY SIRONA INC
• MDR Report Key: 25047383
• Report Number: MW5187520
• Device Sequence Number: 9399704
• Product Code: NXC
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown