FDA Adverse Event
Injury
Summary report: N
BYTE NIGHT ALIGNERS
MDR report key: 22054255
·
Received May 20, 2025
Report
- Report Number
- 3031789024-2025-02545
- Event Type
- Injury
- Date Received
- May 20, 2025
- Report Date
- November 4, 2025
- Manufacturer
- STRAIGHT SMILE LLC
- Product Code
- NXC
- UDI-DI
- 00850017524170
- PMA / PMN Number
- K230199
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803.
Additional Manufacturer Narrative · 0
A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.
Description of Event or Problem · 0
PATIENT REPORTED THEY PROVIDED A LETTER OF RECOMMENDATION TO CEASE TREATMENT. LETTER STATES PATIENT PRESENT WITH CHIEF COMPLAINT OF TEETH NOT "FITTING RIGHT" PATIENT STATES SINCE STARTING BYTE TREATMENT THEIR TEETH ALIGNMENT HAS GOTTEN WORSE. UPON EXAMINATION PATIENT SHOWS 2-3MM OPEN BITE ON THE RIGHT SIDE. PATIENT STATES THEY CANNOT EAT ON THAT SIDE. PATIENT ALSO AT THE SAME TIME HAS A 3MM OVERJET IN THE ANTERIORS. THERE IS ALSO 30% ROTATION OF UPPER CANINE #6, 20 % OF UPPER LATERAL #10. PATIENT WAS ADVISED TO STOP BYTE ALIGNER TREATMENT AND REFERRED TO LOCAL ORTHODONTIST FOR EVAL AND CORRECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2369371 | BYTE NIGHT ALIGNERS | ALIGNER, SEQUENTIAL | NXC | STRAIGHT SMILE LLC | 00850017524170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |