FDA Adverse Event
Injury
Summary report: N
BYTE NIGHT ALIGNERS
MDR report key: 20836237
·
Received December 3, 2024
Report
- Report Number
- 3014845255-2024-02893
- Event Type
- Injury
- Date Received
- December 3, 2024
- 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
- US
- Reporter Occupation
- 003
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 REPORTS MEDICAL DOCTOR (MD) ADVISED TO STOP THE BYTE TREATMENT. THERE WERE NO SPECIFIC DETAILS PROVIDED BY THE MD. PAIN LEVEL WAS CLASSIFIED AS 1 BY THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2292582 | BYTE NIGHT ALIGNERS | ALIGNER, SEQUENTIAL | NXC | STRAIGHT SMILE, LLC | NBYTE TRAY | 00850017524170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |