InBrace Teeth Straightening System (Gen 2.0) Fitting KitRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850018135047), received between Nov 8, 2022 and Dec 2, 2022 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING REMOVAL OF THE LOWER SMARTWIRE FOR A ROUTINE WIRE CHANGE, THE BRACKET ON THE LOWER RIGHT 5 PREMOLAR TOOTH DEBONDED. THE BRACKET CONTAINED AN ADHESIVE AND A SMALL AMOUNT OF TOOTH STRUCTURE WHICH APPEARED TO BE TOOTH ENAMEL.

  Patient problems: Tooth Fracture

  MAUDE report 15902395 ↗
• InjuryNov 8, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT EXPERIENCED AN ORTHODONTIC WIRE EMBEDDED INTO THE LINGUAL GINGIVA, BETWEEN THE UPPER ANTERIOR TOOTH # 8 AND # 9. THE WIRE WAS CUT INTO SECTIONS AND EACH SECTION REMOVED BY PULLING THROUGH THE GINGIVA.. THE PATIENT WAS INSTRUCTED TO RINSE THE MOUTH WITH WARM SALT WATER AND ALOW 4-5 WEEKS TO HEAL THE TISSUE PRIOR TO INSERTION OF A NEW WIRE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15756633 ↗