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

Model Number	8612
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Tooth Fracture (2428); Tooth Loss (4831)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The treating doctor reported that the patient required tooth extraction (tooth #30) after an abscess and 3 broken roots (same tooth).Patient didn't need any medical intervention.No lab/ test was performed.Medications were not prescribed for this patient.
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 said that the potential root cause of this event could have been that the aligners aggravated the situation and due to the preexisting conditions.Align's clinical review of available records indicates the tooth 30 had a crown with buccal gum recession showing the metal edge from this crown and apparently a root canal treatment due to the occlusal restoration present on the crown, however, root canal cannot be confirmed since no radiographs are present.Additional aligners scans showed that teeth 29, 30 and 31 became a bridge due to extraction of tooth 30.No conclusive evidence has been provided that supports or opposes whether the invisalign system caused or contributed to the required tooth extraction (permanent impairment), therefore, this event it is being filed as an mdr per 21 cfr 803.There is no conclusive evidence to confirm the date of the symptoms, and the date (b3) is based on the timelines reported to align and compared to the patient information.
Additional Manufacturer Narrative
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• Brand Name: INVISALIGN GO
• 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: 21363691
• Report Number: 2953749-2025-00319
• Device Sequence Number: 8437870
• Product Code: NXC
• UDI-Device Identifier: 00816063020127
• UDI-Public: (01)00816063020127(10)0184872439(13)240516(91)19205538XXN
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2025

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: 8612
• Device Catalogue Number: 8612
• Device Lot Number: 184872439
• 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: 01/26/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2024
• 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: 54 YR
• Patient Sex: Female