INVISALIGN FIRST - COMPREHENSIVE
Received Jul 15, 2026 · Event occurred Jul 4, 2026
Report 2953749-2026-02222 · MDR key 25828245
Device
Generic name
Aligner, Sequential
Manufacturer
Align Technology, Inc.Model number
9007Lot number
243737017
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
9 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CLINIC STAFF REPORTED THAT THE PATIENT SWALLOWED A BROKEN FRAGMENT OF AN ALIGNER. THE PATIENT REPORTED VISITING THE HOSPITAL AND REQUIRED MEDICAL INTERVENTION CONSISTING OF EVALUATION AND DISCHARGE WITH INSTRUCTIONS TO MONITOR STOOL FOR PASSAGE OF THE SWALLOWED FRAGMENT.
Additional Manufacturer Narrative
THE CURRENT INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING: WARNINGS- ORTHODONTIC APPLIANCES, OR PARTS THEREOF, MAY BE ACCIDENTLY SWALLOWED OR ASPIRATED AND MAY BE HARMFUL." THE CLINIC STAFF SHARED THAT THE POTENTIAL ROOT CAUSE COULD HAVE BEEN PROLONGED WEAR OF THE LAST ALIGNER, EXCEEDING THE RECOMMENDED WEAR PERIOD FOR A SINGLE SET OF ALIGNERS. THERE IS NO CONCLUSIVE EVIDENCE PROVIDED THAT SUPPORTS OR OPPOSES WHETHER THE INVISALIGN SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED LIFE-THREATENING EVENT AND OTHER SERIOUS IMPORTANT MEDICAL EVENTS. BASED ON THE AVAILABLE INFORMATION, THE PATIENT EXPERIENCED A LIFE-THREATENING EVENT AND OTHER SERIOUS IMPORTANT MEDICAL EVENTS WHILE THE INVISALIGN SYSTEM WAS BEING USED. THEREFORE, AN MDR WILL BE FILED IN THE UNITED STATES PER 21 CFR 803.