FDA Adverse Event
Malfunction
Summary report: N
BYTE DAY ALIGNER
MDR report key: 19667113
·
Received July 3, 2024
Report
- Report Number
- 3014845255-2024-00549
- Event Type
- Malfunction
- Date Received
- July 3, 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 GUMS. THEY ALSO ARE HAVING PAIN IN THEIR JAW, EARS AND A CONSTANT HEADACHE WHEN WEARING THIS STEP OF ALIGNERS. ALIGNERS DON'T FIT WELL. PROVIDED PATIENT WITH TIPS ON FILING SHARP EDGES. ALIGNERS LOOK NOT TO FIT WITH IN NORMAL LIMITS. PROVIDED WARM WATER TIP AND REQUESTED MORE INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 800313 | BYTE DAY ALIGNER | ALIGNER, SEQUENTIAL | NXC | STRAIGHT SMILE , LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |