FDA Adverse Event
Malfunction
Summary report: N
BYTE RETAINER
MDR report key: 20287545
·
Received September 23, 2024
Report
- Report Number
- 3014845255-2024-01181
- Event Type
- Malfunction
- Date Received
- September 23, 2024
- Report Date
- November 24, 2025
- Manufacturer
- STRAIGHT SMILE, LLC
- Product Code
- KMY
- UDI-DI
- 00850017524187
- 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 DENTIST HAS ASKED THEM TO STOP USING THE RETAINERS DUE TO THE SHARP EDGES CAUSING CUTS AND ULCERATIONS. THE DENTIST IS CONCERNED THAT THEY WILL INJURE THEIR LOWER TEETH. REQUESTED ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1091006 | BYTE RETAINER | POSITIONER, TOOTH, PREFORMED | KMY | STRAIGHT SMILE, LLC | BYTERETAINER | 00850017524187 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |