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iGO Plus 9017Recalls & reported problems

Align Technology, Inc. · Sequential Aligner · Class 2

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 00816063020479), received between Jul 26, 2023 and Jul 26, 2023 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Tooth Fracture1
  • Tooth Loss1

Recent adverse event reports

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

  • InjuryJul 26, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    THE PATIENT REPORTED FRACTURE AND EXTRACTION OF TOOTH 2.5. THE PATIENT WAS PRESCRIBED ANTIBIOTIC CLAVULI TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT IS CONTINUING THE USE OF THE ALIGNERS AND IS CURRENTLY ASYMPTOMATIC.

    Patient problems: Tooth Fracture; Tooth Loss

    MAUDE report 17397268 ↗

Other Aligner, Sequential devices

All Aligner, Sequential devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.