FDA Adverse Event
Injury
Summary report: N
BYTE DAY ALIGNERS
MDR report key: 20922042
·
Received December 13, 2024
Report
- Report Number
- 3014845255-2024-02977
- Event Type
- Injury
- Date Received
- December 13, 2024
- Report Date
- November 7, 2025
- Manufacturer
- STRAIGHT SMILE, LLC
- Product Code
- NXC
- UDI-DI
- 00850017524163
- PMA / PMN Number
- K230199
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
RETRIEVING DATA. WAIT A FEW SECONDS AND TRY TO CUT OR COPY AGAIN.
Additional Manufacturer Narrative · 0
A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.
Description of Event or Problem · 0
"FRONT TEETH AND BACK TEETH ARE THE ONLY TEETH THAT TOUCH."" (B)(6) 2024- CASE (B)(4)- EMAIL ""I WOULD DEFINITELY LIKE TO SPEAK WITH DR. (B)(6)"" 8/2 DR. (B)(6) MET WITH THE CUSTOMER AND REVIEW HER UPDATED BITE VIDEO. BITE HAS SETTLED ENOUGH FOR US TO MOVE FORWARD WITH DUAL REFINEMENT. HN. (B)(6) 2024 UPDATE: ""UPPER & LOWER TEETH NEED MORE STRAIGHTENING/OPEN BITE, CROWDING, STRAIGHTENING OUT, TIMELINE"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1923517 | BYTE DAY ALIGNERS | ALIGNER, SEQUENTIAL | NXC | STRAIGHT SMILE, LLC | HBYTE TRAY | NA | 00850017524163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |