FDA Adverse Event
Malfunction
Summary report: N
BYTE RETAINER
MDR report key: 19670927
·
Received July 3, 2024
Report
- Report Number
- 3014845255-2024-00564
- Event Type
- Malfunction
- Date Received
- July 3, 2024
- Report Date
- October 7, 2025
- Manufacturer
- STRAIGHT SMILE, LLC
- Product Code
- KMY
- 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 RETAINERS, PATIENT REPORTS THAT THEIR ALIGNERS ARE CUTTING INTO THEIR GUMS AND IS UNCOMFORTABLE. THEY HAVE TRIED FILING THEM, BUT IT HAS NOT HELPED. PROVIDED FIT TIPS AND SOAK ALIGNER IN WARM WATER. REQUESTED PATIENT TO UPDATE AFTER TRYING TIPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 446788 | BYTE RETAINER | POSITIONER, TOOTH, PREFORMED | KMY | STRAIGHT SMILE, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |