FDA Adverse Event
Injury
Summary report: N
BYTE RETAINER
MDR report key: 20124909
·
Received September 3, 2024
Report
- Report Number
- 3014845255-2024-00896
- Event Type
- Injury
- Date Received
- September 3, 2024
- Report Date
- October 8, 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 BITE WORSENING, PRIOR TO TREATMENT THEY DID NOT HAVE AN UNDERBITE BUT NOW THEY DO. REQUESTED ADDITIONAL INFORMATION FROM PATIENT, HAVE SENT THREE FOLLOW UP REQUESTS, NO RESPONSE FROM PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 734915 | BYTE RETAINER | POSITIONER, TOOTH, PREFORMED | KMY | STRAIGHT SMILE, LLC | 00850017524187 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |