MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN SYSTEM - EXPRESS; ALIGNER, SEQUENTIAL

Model Number	9003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Tooth Fracture (2428); Tooth Loss (4831)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
The current instructions for use (ifu) contains the following: "precautions - a tooth that has been previously traumatized or significantly restored may be aggravated.In rare instances, the 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.".The treating doctor shared that the primary factor contributing to the extraction was likely a microfracture resulting from a past car accident, which may have deteriorated gradually.However, the doctor did not rule out the possibility that orthodontic treatment may have aggravated the pre existing condition.Align's clinical review of available records indicates that although the patient had completed multiple prior treatment orders and was on stage 1 of a secondary order, tooth movement forces may potentially aggravate an underlying structural weakness.There is no conclusive evidence provided that supports or opposes whether the invisalign system aligners caused or contributed to the reported tooth loss.Based on the available information and the clinical assessment below, the treating doctor reported that the patient required tooth extraction, and the invisalign system aligners were being used.Therefore, an mdr will be filed in the united states per 21 cfr 803.

• Brand Name: INVISALIGN SYSTEM - EXPRESS
• 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 santana ; 2820 orchard parkway; san jose, CA 95134
• MDR Report Key: 24307102
• Report Number: 2953749-2026-00247
• Device Sequence Number: 21247928
• Product Code: NXC
• UDI-Device Identifier: 00816063020219
• UDI-Public: (01)00816063020219(10)0242781008(13)251214(91)2837173001N
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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: 9003
• Device Lot Number: 242781008
• 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: 01/16/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2025
• 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: Disability
• Patient Age: 31 YR
• Patient Sex: Female