FDA Adverse Event
Injury
Summary report: N
BYTE DAY ALIGNER
MDR report key: 19872586
·
Received July 31, 2024
Report
- Report Number
- 3014845255-2024-00718
- Event Type
- Injury
- Date Received
- July 31, 2024
- Report Date
- October 11, 2025
- Manufacturer
- STRAIGHT SMILE , LLC
- Product Code
- NXC
- PMA / PMN Number
- K180346
- Adverse Event
- 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 THEY HAVE PAIN IN THEIR JAW WITH THE LOWER ALIGNERS. THE PATIENT'S TWO WISDOM TEETH HAVE BECOME IMPACTED AND SWELLING IN THE AREA. THE TWO TEETH WERE REMOVED. SINCE THE TEETH WERE REMOVED THE ALIGNER NOW CUTS THE PATIENT'S MOUTH IN THE BACK. EDUCATED PATIENT ON J-SHAPED ALIGNERS AND JAW DISCOMFORT. REQUESTED ADDITIONAL INFORMATION. ADVISED TO REMAIN IN STEP 1 AND TRY ON ALIGNER AFTER GUMS HAVE HEALED FROM EXTRACTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 835325 | BYTE DAY ALIGNER | ALIGNER, SEQUENTIAL | NXC | STRAIGHT SMILE , LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |