InjuryKMY
BYTE RETAINER
Received Jun 25, 2026
Report 3031789024-2026-02811 · MDR key 25620601
Device
Generic name
Positioner, Tooth, Preformed
Manufacturer
Straight Smile LlcModel number
BYTERETAINERTRAYCatalog number
PRS-0063
Lot number
MD2621TBRT
Product problems
- Patient-Device Incompatibility
Patient
NA · Unknown
- Deformity/ Disfigurement
- Tooth Fracture
Narrative
Additional Manufacturer Narrative
SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803.
Description of Event or Problem
PATIENT STATED THAT THEY EXPERIENCED UNINTENDED MOVEMENT THAT CAUSED AN OPEN BITE AND A FRACTURED TOOTH DUE TO BYTE RETAINER.