InjuryKMY
BYTE RETAINER
Received Jul 21, 2026
Report 3031789024-2026-02826 · MDR key 25889801
Device
Generic name
Positioner, Tooth, Preformed
Manufacturer
Straight Smile LlcModel number
BYTERETAINERTRAYCatalog number
PRS-0063
Lot number
MD6851EGRT
Product problems
- Patient-Device Incompatibility
Patient
NA · Unknown
- Tissue Breakdown
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 RECESSION DUE TO BYTE RETAINER.