FDA Adverse Event
Malfunction
Summary report: N
BYTE RETAINER
MDR report key: 19715700
·
Received July 10, 2024
Report
- Report Number
- 3014845255-2024-00604
- Event Type
- Malfunction
- Date Received
- July 10, 2024
- Report Date
- October 8, 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 REPORTED THAT THEIR RETAINERS ARE CUTTING THEIR GUMS. PROVIDED HHT&T TIPS AND TO USE FILE TO SMOOTH SHARP/ROUGH EDGES. BLANCHING IS PRESENT AROUND TOOTH #9.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 367078 | BYTE RETAINER | POSITIONER, TOOTH, PREFORMED | KMY | STRAIGHT SMILE, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |