FDA Adverse Event
Malfunction
Summary report: N
BYTE NIGHT ALIGNER
MDR report key: 20329531
·
Received September 29, 2024
Report
- Report Number
- 3014845255-2024-01282
- Event Type
- Malfunction
- Date Received
- September 29, 2024
- Report Date
- October 8, 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 ALIGNERS CUTTING THEIR TONGUE. THEY HAVE FILED THEM DOWN AND HAVE USED ORTHO WAX. THEY WENT TO THE NEXT STEP ALIGNER AND THEY DO NOT CUT THEIR TONGUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1052782 | BYTE NIGHT ALIGNER | ALIGNER, SEQUENTIAL | NXC | STRAIGHT SMILE , LLC | NBTYE TRAY | 00850017524170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |