FDA Adverse Event
Injury
Summary report: N
BYTE RETAINER
MDR report key: 19931917
·
Received August 7, 2024
Report
- Report Number
- 3014845255-2024-00754
- Event Type
- Injury
- Date Received
- August 7, 2024
- Report Date
- November 24, 2025
- Manufacturer
- STRAIGHT SMILE, LLC
- Product Code
- KMY
- UDI-DI
- 00850017524187
- 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 RETAINERS, PATIENT REPORTED THAT RETAINER IS HARD TO GET ON AND IMPOSSIBLE TO GET OFF, PATIENT NOTED SENSITIVITY AND CHIPPED TOOTH. REQUESTED INFORMATION ON SENSITIVITY AND CHIPPING OF TOOTH. REQUESTED PATIENT TO SOAK RETAINERS AND THEN PROVIDE A VIDEO OF THEM PLACING AND REMOVING THEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 546232 | BYTE RETAINER | POSITIONER, TOOTH, PREFORMED | KMY | STRAIGHT SMILE, LLC | 00850017524187 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |