FDA Adverse Event
Malfunction
Summary report: N
BYTE NIGHT ALIGNER
MDR report key: 19838100
·
Received July 26, 2024
Report
- Report Number
- 3014845255-2024-00705
- Event Type
- Malfunction
- Date Received
- July 26, 2024
- Report Date
- October 11, 2025
- Manufacturer
- STRAIGHT SMILE , LLC
- Product Code
- NXC
- UDI-DI
- 00850017524170
- PMA / PMN Number
- K180346
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.
Additional Manufacturer Narrative · 0
SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803.
Description of Event or Problem · 0
WHILE USING A BYTE NIGHT ALIGNERS, PATIENT REPORTED THAT THEY HAVE A LOT OF DISCOMFORT IN THEIR FRONT TOP TEETH. WHEN THEY REMOVE THE ALIGNER, THEIR UPPER GUM IS BRUISED AND BLOODY. PROVIDED HH, BLANCHING AND GUM TISSUE TIPS, GENTLY FILE AREA OF ALIGNER TO SMOOTH AND REQUESTED UPDATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1528585 | BYTE NIGHT ALIGNER | ALIGNER, SEQUENTIAL | NXC | STRAIGHT SMILE , LLC | 00850017524170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |