FDA Adverse Event
Malfunction
Summary report: N
BYTE DAY ALIGNER
MDR report key: 20340790
·
Received September 30, 2024
Report
- Report Number
- 3014845255-2024-01308
- Event Type
- Malfunction
- Date Received
- September 30, 2024
- Report Date
- November 28, 2025
- Manufacturer
- STRAIGHT SMILE , LLC
- Product Code
- NXC
- UDI-DI
- 00850017524163
- 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 DAY ALIGNERS, PATIENT REPORTED THE ALIGNERS VERY TIGHT, PAINFUL AND ROUGH CAUSING SO MANY CUTS UNDER THEIR TONGUE. THEY HAD TO FILE THEM AND BUY ORTHO WAX. WHEN THEY REMOVE THE ALIGNERS, IT FEELS LIKE THEY ARE PULLING OUT THEIR TEETH. THEY HAVE TO TAKE BREAKS FROM WEARING ALIGNERS AND TAKE TYLENOL. PROVIDED FIT AND GENERAL DISCOMFORT TIPS AND ASKED FOR A FOLLOW UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2351527 | BYTE DAY ALIGNER | ALIGNER, SEQUENTIAL | NXC | STRAIGHT SMILE , LLC | HBYTE TRAY | 00850017524163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |