InjuryKMY
Byte Retainer
Received Jul 27, 2026
Report 3031789024-2026-02834 · MDR key 50008316
Device
Generic name
Positioner, Tooth, Preformed
Manufacturer
Straight Smile LlcModel number
BYTERetainerTrayCatalog number
PRS-0063
Lot number
MD1991DGRT
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Deformity/ Disfigurement
Narrative
Description of Event or Problem
Patient stated that they experienced bone loss due to Byte retainer.
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 CFR Part 803.