FDA Adverse Event
Injury
Summary report: N
BYTE NIGHT ALIGNERS
MDR report key: 21196418
·
Received January 21, 2025
Report
- Report Number
- 3014845255-2024-03895
- Event Type
- Injury
- Date Received
- January 21, 2025
- Report Date
- November 4, 2025
- Manufacturer
- STRAIGHT SMILE, LLC
- Product Code
- NXC
- UDI-DI
- 00850017524170
- PMA / PMN Number
- K230199
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.
Additional Manufacturer Narrative · 0
SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21CFR PART 803. THERE IS NO CHANGE TO DEVICE PERFORMANCE OR TO THE DEVICE RISK PROFILE. A CAPA (2023-487) HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.
Description of Event or Problem · 0
THE CUSTOMER REPORTED THAT THEY ARE EXPERIENCING PAIN THAT GOES TO THE ROOT AND THAT THE TOP TEETH ARE SLIGHTLY PUSHED. NO ADDITIONAL INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 663814 | BYTE NIGHT ALIGNERS | ALIGNER, SEQUENTIAL | NXC | STRAIGHT SMILE, LLC | NBYTE TRAY | NA | 00850017524170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |