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

Swift Health Systems Inc. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850018135054), received between Dec 2, 2022 and Dec 2, 2022 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Tooth Fracture1

Recent adverse event reports

The 1 most recent of 1 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 LEFT 4 PREMOLAR TOOTH DEBONDED. THE BRACKET CONTAINED AN ADHESIVE AND A SMALL AMOUNT TOOTH STRUCTURE WHICH APPEARED TO BE TOOTH ENAMEL.

    Patient problems: Tooth Fracture

    MAUDE report 15902376 ↗

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Sources and updates

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