inforMED
InjuryNXC

INVISALIGN SYSTEM - COMPREHENSIVE

Received Jul 22, 2026 · Event occurred Jul 7, 2026

Report 2953749-2026-02225 · MDR key 25907765

Device

Generic name

Aligner, Sequential

Model number

9000

Lot number

257155373

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

34 YR · Female

  • Bacterial Infection
  • Tooth Loss

Narrative

Additional Manufacturer Narrative

HE CURRENT INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING: "PRECAUTIONS - A TOOTH THAT HAS BEEN PREVIOUSLY TRAUMATIZED OR SIGNIFICANTLY RESTORED MAY BE AGGRAVATED. IN RARE INSTANCES, THE USEFUL LIFE OF THE TOOTH MAY BE REDUCED, THE TOOTH MAY REQUIRE ADDITIONAL DENTAL TREATMENT SUCH AS ENDODONTIC AND/OR ADDITIONAL RESTORATIVE WORK, AND/OR THE TOOTH MAY BE LOST.". NO ROOT CAUSE PROVIDED. ALIGN'S CLINICAL REVIEW NOTED INITIAL UPPER OCCLUSAL PHOTOGRAPHS SHOWED A RESTORATION WITH SIGNS OF MARGINAL LEAKAGE AND A FRACTURED MESIOBUCCAL PORTION OF THE TOOTH. SUBSEQUENT PHOTOGRAPHS OBTAINED DURING AN ADDITIONAL ALIGNER PHASE IN OCTOBER 2024 SHOWED FURTHER DETERIORATION OF THE RESTORATION AND BROWNISH DISCOLORATION ALONG THE MESIAL MARGIN. IMAGES FROM APRIL 2026, FOLLOWING COMPLETION OF AN ADDITIONAL 34 ALIGNERS, SHOWED THAT TOOTH 1.7 HAD BEEN RESTORED AND THAT THE PALATAL ASPECT OF THE RESTORATION APPEARED FRACTURED. CLINICAL RECORDS DOCUMENTED PROGRESSIVE CHANGES IN THE CONDITION OF TOOTH 1.7 DURING TREATMENT. THERE IS NO CONCLUSIVE EVIDENCE PROVIDED THAT SUPPORTS OR OPPOSES WHETHER THE INVISALIGN SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED PERMANENT DAMAGE. BASED ON THE AVAILABLE INFORMATION, THE PATIENT HAD PERMANENT DAMAGE, AND THE INVISALIGN SYSTEM WAS BEING USED. THEREFORE, AN MDR WILL BE FILED IN THE UNITED STATES PER 21 CFR 803. THE EXACT DATE OF THE EVENT IS UNKNOWN. DESPITE REASONABLE EFFORTS, NO CONCLUSIVE INFORMATION WAS AVAILABLE TO DETERMINE WHEN THE EVENT OCCURRED. THE DATE (B3) PROVIDED CORRESPONDS TO THE DATE THE EVENT WAS REPORTED TO THE MANUFACTURER AND DOES NOT NECESSARILY REFLECT THE ACTUAL DATE OF OCCURRENCE.

Description of Event or Problem

THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF SEVERE TOOTH INFECTION, TOOTH EXTRACTION (TOOTH 1.7), BUCCAL DECAY ON TOOTH 4.7, AND UPPER AND LOWER ALIGNERS NOT FITTING PROPERLY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT WERE UNSUCCESSFUL.