MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN FIRST - COMPREHENSIVE.; ALIGNER, SEQUENTIAL

Model Number	9007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	04/19/2026
Type of Reportable Event	Serious Injury
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 treating doctor shared that the potential root cause could have been the aligner breaking, which resulted in a fragment being swallowed.Align's clinical review noted that the treating doctor reported a fracture of the aligner in the lower left canine region (tooth 3.3) during treatment with the invisalign secondary order at stage 34, with a fragment reportedly swallowed by the patient.The patient subsequently experienced breathing discomfort, sought hospital care, was hospitalized, evaluated, and stabilized, and is currently in good condition with no ongoing complications.No medical records, diagnostic imaging, laboratory tests, or additional clinical documentation were provided for review, and no permanent sequelae were reported.There is no conclusive evidence provided that supports or opposes whether the invisalign system caused or contributed to the reported hospitalization (initial or prolonged).Based on the available information, the patient had hospitalization (initial or prolonged), and the invisalign system was being used.Therefore, an mdr will be filed in the united states per 21 cfr 803.There is no conclusive evidence to confirm the exact date of the event, and the date (b3) is based on the timelines reported to align and compared to patient information.
Event or Problem Description
The treating doctor reported that the patient had symptoms of breathing discomfort after inadvertently swallowing a fragment of a fractured aligner while using the invisalign system (secondary order, stage 34).The patient reported visiting the hospital and required medical intervention, including hospitalization, where the patient was evaluated and stabilized, and is currently in good condition with no ongoing complications.The patient indicated being prescribed tab ibastin (ebastine) to alleviate the reported symptoms and the patient is currently asymptomatic.

• Brand Name: INVISALIGN FIRST - COMPREHENSIVE.
• Common Device Name: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer (Section G): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: janier duarte ; 2820 orchard parkway; san jose, CA 95134
• MDR Report Key: 25444444
• Report Number: 2953749-2026-02041
• Device Sequence Number: 5938838
• Product Code: NXC
• UDI-Device Identifier: 00816063020264
• UDI-Public: (01)00816063020264(10)0214458758(13)260318(91)2144269434N
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K241412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 9007
• Device Lot Number: 214458758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 9 YR
• Patient Sex: Female