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 Codes	Abscess (1690); Sensitivity of Teeth (2427); Tooth Loss (4831)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The treating doctor reported that the patient had symptoms of abscesses between different teeth, grade ii tooth mobility, sensitivity, tenderness to palpation and tooth loss (tooth #1.7).The patient did not report requiring any medical intervention for the reported symptoms.The patient indicated being prescribed antibiotics to alleviate the reported symptoms.It is unknown if any clinical or laboratory tests were performed.The patient is currently reported to be getting better.
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."," the health of the bone and gums which support the teeth may be impaired or aggravated.".The treating doctor shared that the potential root cause could have been mesiodistal movements associated with the aligner treatment, although a direct relationship could not be confirmed.Align's clinical review noted that tooth 1.7 did not have any programmed movement throughout the 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.

• 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 ; 2820 orchard parkway; san jose, CA 95134
• MDR Report Key: 25094531
• Report Number: 2953749-2026-01595
• Device Sequence Number: 5005187
• Product Code: NXC
• UDI-Device Identifier: 00816063020431
• UDI-Public: (01)00816063020431(10)0226421574(13)250711(91)2432830021N
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 05/06/2026

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: 226421574
• 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: 04/16/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2025
• 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: 34 YR
• Patient Sex: Female