FDA Adverse Event
Injury
Summary report: N
BYTE RETAINER
MDR report key: 20263337
·
Received September 19, 2024
Report
- Report Number
- 3014845255-2024-01109
- Event Type
- Injury
- Date Received
- September 19, 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 THEIR INITIAL TREATMENT DID HELP BUT THEIR BITE FEELS OFF WITH THEIR MOLARS. THEY CAN'T TOUCH THEIR FRONT TEETH TOGETHER BECAUSE THEIR MOLARS DO NOT LINE UP AND THEIR FRONT TEETH TOO FAR OUT. REQUESTED ADDITIONAL INFORMATION, EDUCATED PATIENT ON HOW WE ARE NOT ABLE TO MOVE MOLARS AND ASKED IF THEY WOULD LIKE TO PROCEED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 242759 | BYTE RETAINER | POSITIONER, TOOTH, PREFORMED | KMY | STRAIGHT SMILE, LLC | BYTERETAINER | 00850017524187 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |