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

Model Number	9012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The current instructions for use contains the following: "a tooth that has been previously traumatized or significantly restored may be aggravated and/or the tooth may be lost." the potential root cause of this event is unknown.Align's clinical review of available records indicates that initial treatment plans attempted to create space for anterior crowding; however, sufficient space could not be achieved to align the anterior teeth and position ur3.The extraction of ur4 may have been part of the treatment plan; however, a contribution from the aligners cannot be ruled out.No conclusive evidence has been provided that supports or opposes whether the invisalign system aligners caused or contributed to the reported tooth loss.Based on the available information and align's clinical assessment, the patient required tooth extraction resulting in permanent damage to a body structure, and the invisalign system aligners were being used.Therefore, an mdr will be filed in the united states per 21 cfr 803.
Event or Problem Description
The treating doctor reported that the patient required extraction of tooth ur4.It is unknown if the patient required additional medical intervention or medications to alleviate the reported event.It is unknown whether the patient discontinued the aligners, and the patient's current condition is unknown.

• Brand Name: INVISALIGN GO PLUS
• 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: 24240247
• Report Number: 2953749-2026-00196
• Device Sequence Number: 9220829
• Product Code: NXC
• UDI-Device Identifier: 00816063020431
• UDI-Public: (01)00816063020431(10)0225331398(13)250630(91)2521236314N
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/02/2026

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: 9012
• Device Lot Number: 225331398
• 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: 01/06/2026
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2025
• 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: 39 YR
• Patient Sex: Male