FDA Adverse Event
Malfunction
Summary report: N
BYTE NIGHT ALIGNER
MDR report key: 20091421
·
Received August 28, 2024
Report
- Report Number
- 3014845255-2024-00873
- Event Type
- Malfunction
- Date Received
- August 28, 2024
- Report Date
- October 7, 2025
- Manufacturer
- STRAIGHT SMILE , LLC
- Product Code
- NXC
- UDI-DI
- 00850017524170
- PMA / PMN Number
- K230199
- Product Problem
- 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 REPORTED THAT THEIR TOP ALIGNERS ARE CUTTING INTO THEIR GUMS AND ARE MAKING THEIR TEETH THROB BECAUSE THE ALIGNERS DON'T FIT WELL. PROVIDED FIT TIPS, FILING ALIGNER AND REQUESTED UPDATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1494861 | BYTE NIGHT ALIGNER | ALIGNER, SEQUENTIAL | NXC | STRAIGHT SMILE , LLC | 00850017524170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |