FDA Adverse Event
Injury
Summary report: N
BYTE NIGHT ALIGNER
MDR report key: 18896897
·
Received March 13, 2024
Report
- Report Number
- 3014845255-2024-00155
- Event Type
- Injury
- Date Received
- March 13, 2024
- Report Date
- December 2, 2025
- Manufacturer
- STRAIGHT SMILE , LLC
- Product Code
- NXC
- PMA / PMN Number
- K180346
- 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
WHILE USING A BYTE NIGHT ALIGNERS, PATIENT EXPERIENCED JAW PAIN, IN PATIENT'S RIGHT TMJ. THE PATIENT WAS EXAMINED BY THEIR DENTIST AND ADVISED TO DISCONTINUE ALIGNER TREATMENT PENDING EVALUATION WITH OMFS TO DETERMINE IF THIS CONDITION IS PROGRESSIVE, RELATED TO THE MOVEMENT OF PATIENT'S TEETH, AND/OR ANY TREATMENT REQUIRED TO REMEDY PATIENT'S PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1017521 | BYTE NIGHT ALIGNER | ALIGNER, SEQUENTIAL | NXC | STRAIGHT SMILE , LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |