FDA Adverse Event
Malfunction
Summary report: N
BYTE DAY ALIGNER
MDR report key: 19715200
·
Received July 10, 2024
Report
- Report Number
- 3014845255-2024-00609
- Event Type
- Malfunction
- Date Received
- July 10, 2024
- Report Date
- November 22, 2025
- Manufacturer
- STRAIGHT SMILE , LLC
- Product Code
- NXC
- 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 DAY ALIGNERS, PATIENT REPORTED THAT THEIR ALIGNERS ARE CUTTING INTO THEIR TONGUE. PATIENT PROVIDED PICTURE SHOWING THE LOWER ANTERIOR LINGUAL AREA OF THEIR FINAL ALIGNER AS THE CAUSE. ADVISED TO TRY HHT&T TIPS AND FILE ANY SHARP EDGES GENTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 367055 | BYTE DAY ALIGNER | ALIGNER, SEQUENTIAL | NXC | STRAIGHT SMILE , LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |