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

Model Number	9000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 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 indicated that, on the initial panoramic x-ray prior to the start of treatment, tooth 2.6 was already absent and replaced by a dental bridge.Tooth 2.4 appeared to be restored with a single crown and showed evidence of prior endodontic treatment, including a radiopaque structure consistent with a post.Teeth 2.5 and 2.7 appeared to serve as abutments of the bridge and were also endodontically treated, with radiographic findings suggestive of metal posts and dental crowns.The prescribing doctor indicated that these teeth should remain unmovable throughout four rounds of 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.
Event or Problem Description
The treating doctor reported that the patient had symptoms of extraction of teeth 2.4, 2.5, 2.6, and 2.7.It is unknown if the patient required any medical intervention related to the reported symptoms.It is unknown if the patient was prescribed or took any medications to alleviate the reported symptom(s).It is unknown if any clinical or laboratory tests were performed.It is unknown if the treatment was discontinued or if the patient is still using the invisalign system, and the patient's current condition is unknown.

• Brand Name: INVISALIGN SYSTEM - 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: 25394428
• Report Number: 2953749-2026-02085
• Device Sequence Number: 13429845
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0203661553(13)241126(91)923877814N
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 06/04/2026

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: 9000
• Device Lot Number: 203661553
• 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: 05/22/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2024
• 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: 67 YR
• Patient Sex: Female