FDA Adverse Event
Malfunction
Summary report: N
BYTE DAY ALIGNER
MDR report key: 19921560
·
Received August 6, 2024
Report
- Report Number
- 3014845255-2024-00748
- Event Type
- Malfunction
- Date Received
- August 6, 2024
- Report Date
- October 21, 2025
- Manufacturer
- STRAIGHT SMILE , LLC
- Product Code
- NXC
- UDI-DI
- 00850017524163
- 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 LOWER ALIGNER IS CUTTING INTO THEIR GUM. THEY HAVE TRIED FILING THE AREA, BUT IT IS STILL CUTTING THEM. PROVIDED HH TIPS. AND REQUESTED, UPDATED PHOTOS WEARING STEPS 1 & 2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1661666 | BYTE DAY ALIGNER | ALIGNER, SEQUENTIAL | NXC | STRAIGHT SMILE , LLC | 00850017524163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |