Invisalign System - Express 9003Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00816063020219), received between Apr 18, 2023 and Feb 10, 2026 — classified as 5 injuries.

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT EXPERIENCED A ROOT FRACTURE ON TOOTH #12 AND REQUIRED EXTRACTION. THE PATIENT REPORTED SYMPTOMS OF PAIN PRIOR TO THE EXTRACTION. THE PATIENT REQUIRED MEDICAL INTERVENTION A BONE GRAFT, AND LEAVING THE SPACE FOR AN IMPLANT AND CROWN. THE PATIENT WAS PRESCRIBED ANTIBIOTICS, PHENERGAN, AND A MEDROL DOSE PACK TO MANAGE SYMPTOMS ASSOCIATED WITH THE REPORTED ADVERSE EVENT. THE PATIENT INDICATED TAKING MEDICATIONS REGULARLY, BUT SPECIFIC MEDICATIONS WERE NOT PROVIDED. THE PATIENT DID NOT DISCONTINUE USE OF THE INVISALIGN SYSTEM ALIGNERS. THE PATIENT IS REPORTEDLY IMPROVING PER THE TREATING DOCTOR.

  Patient problems: Pain; Tooth Fracture; Tooth Loss

  MAUDE report 24307102 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTS THAT THE PATIENT LOST TOOTH 1.6. THE REPORTED SYMPTOMS DO NOT APPEAR TO BE LIFE THREATENING TO THE PATIENT, EITHER INDIVIDUALLY OR IN COMBINATION OF SYMPTOMS. IT IS UNKNOWN IF THE PATIENT REQUIRED MEDICAL INTERVENTION OR IF MEDICATIONS WERE PRESCRIBED TO ALLEVIATE THE REPORTED SYMPTOMS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Tooth Loss

  MAUDE report 22531089 ↗
• InjuryDec 1, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED SYMPTOMS OF TINNITUS, RINGING IN THE EAR, HEARING LOSS (90% HEARING LOSS IN RIGHT EAR AND SOME HEARING LOSS IN LEFT EAR). THE PATIENT REPORTED REQUIRING VISITING AN AUDIOLOGIST AND AN ENT TO ADDRESS THE REPORTED SYMPTOMS. THE PATIENT DID NOT REPORT REQUIRING ANY PRESCRIPTION MEDICATIONS TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT REPORTED DISCONTINUING THE USE OF THE ALIGNERS (DATE UNSPECIFIED) AND IS CURRENTLY GETTING BETTER.

  Patient problems: Partial Hearing Loss

  MAUDE report 18252338 ↗
• InjuryMay 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED EXTRACTION OF TOOTH #2 AND #3 (SCHEDULED). THE REPORTED SYMPTOM DOES NOT APPEAR TO BE SERIOUS OR LIFE THREATENING TO THE PATIENT. THE PATIENT DID NOT REPORT REQUIRING ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT DID NOT REPORT TAKING OR BEING PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT IS CONTINUING THE USE OF THE ALIGNERS AND IS CURRENTLY GETTING BETTER.

  Patient problems: Tooth Loss

  MAUDE report 17007863 ↗
• InjuryApr 18, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED TOOTH #32 CRACKING AND BEING EXTRACTED. IT IS UNKNOWN IF THE PATIENT REQUIRED ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOM. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED ANY MEDICATION. IT IS UNKNOWN IF THE PATIENT IS CONTINUING TO USE THE INVISALIGN SYSTEM ALIGNERS.

  Patient problems: Tooth Fracture; Tooth Loss

  MAUDE report 16763677 ↗