FDA Adverse Event
Malfunction
Summary report: N
BYTE DAY ALIGNER
MDR report key: 19668717
·
Received July 3, 2024
Report
- Report Number
- 3014845255-2024-00553
- Event Type
- Malfunction
- Date Received
- July 3, 2024
- Report Date
- October 7, 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 TOP ALIGNERS ARE CUTTING INTO THEIR GUMS. THEY HAVE HAD TO FILE THE ALIGNERS DOWN CONSIDERABLY. REQUESTED ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 478349 | BYTE DAY ALIGNER | ALIGNER, SEQUENTIAL | NXC | STRAIGHT SMILE , LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |