MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN FULL; ALIGNER, SEQUENTIAL

Model Number	8500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The current instructions for use contains the following: "precautions - the health of the bone and gums which support the teeth may be impaired or aggravated.".No root cause provided.Align's clinical review of available records reveal signs of bone loss localized to the coronal third of the root, which is not classified as severe.However, a comprehensive evaluation of the patient's clinical history is necessary to establish a definitive periodontal diagnosis.No conclusive evidence has been provided that supports or opposes whether the invisalign system aligners caused or contributed to the surgical intervention to prevent permanent damage and the invisalign system aligners being used.Therefore, an mdr is being filed in the united states per 21 cfr 803.
Event or Problem Description
The treating doctor reported that in (b)(6) 2023, the patient noticed that her front teeth appeared as if they were going to fall out.The patient contacted the dental office, where x-rays were taken, and she was informed that the affected tooth could not be saved (according to records and treating doctor information, no teeth were extracted at the end).The patient was subsequently referred to a periodontist.The patient later learned that had a gum infection requiring surgical intervention in two stages.The first surgery occurred on (b)(6) 2024, and the second surgery was performed approximately eight months later.Following completion of the surgeries, the patient was advised that she would not be able to wear aligners for one year.The treating doctor stated that the last time that saw the patient was in 2024 and confirmed that the patient had gum issues and visited a periodontist.It is unknown if further medical intervention or if the patient required any medication, since according to the treating doctor, the patient never went back to the office after visiting the periodontist.

• Brand Name: INVISALIGN FULL
• 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: 23464879
• Report Number: 2953749-2025-02554
• Device Sequence Number: 15940111
• Product Code: NXC
• UDI-Device Identifier: 00816063020004
• UDI-Public: (01)00816063020004(10)0165994524(13)231030(91)0692037301N
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/04/2025

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: 8500
• Device Lot Number: 165994524
• 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: 10/08/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2023
• 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: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female