FDA Adverse Event
Malfunction
Summary report: N
BYTE NIGHT ALIGNER
MDR report key: 19987332
·
Received August 14, 2024
Report
- Report Number
- 3014845255-2024-00799
- Event Type
- Malfunction
- Date Received
- August 14, 2024
- Report Date
- November 24, 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
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 UPPER ALIGNER IS CUTTING INTO THEIR GUM ABOVE THEIR FRONT TEETH AND CAUSING BLEEDING. PROVIDED TIPS, ASKED PATIENT TO FILE SHARP AREA ON ALIGNER AND TO US WARM SALTWATER RINSES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1640580 | BYTE NIGHT ALIGNER | ALIGNER, SEQUENTIAL | NXC | STRAIGHT SMILE , LLC | 00850017524170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |