InjuryKMY
SURESMILE RETAINER
Received Jul 2, 2026 · Event occurred Jun 29, 2026
Report 1649995-2026-00035 · MDR key 25689534
Device
Generic name
Positioner, Tooth, Preformed
Manufacturer
Dentsply Sirona Orthodontics Inc.Catalog number
ASSY-500015
Product problems
- Patient-Device Incompatibility
Patient
NA · Female
- Deformity/ Disfigurement
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
IN THIS EVENT IT IS REPORTED THAT A PATIENT USING SURESMILE RETAINER EXPERIENCED SPACING CREATED BETWEEN TEETH 24 AND 25 ON THE LOWER ARCH. THE HAD TO GO BACK TO WEARING THEIR LAST ALIGNER TO HELP CLOSE THE SPACE AGAIN. THE PATIENT WILL BE RESCANNED FOR NEW RETAINERS