Inbrace Teeth Straightening System Digital EngancementRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850018135122), received between Feb 20, 2023 and Feb 20, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT'S UPPER SMARTWIRE WAS CUT IN HALF DUE A PALATAL SWELLING BETWEEN THE UPPER FRONT TEETH. THE SMARTWIRE WAS PUSHING ON THE PALATE AND HAD TO BE REMOVED. THE ORTHODONTIST REMOVED THE WIRE AND REQUESTED A WIRE REPLACEMENT.

  Patient problems: Inflammation

  MAUDE report 16406097 ↗