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

Model Number	INVISALIGN SYSTEM LITE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bacterial Infection (1735); Ulcer (2274); Swelling/ Edema (4577)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The treating doctor reported that the patient had symptoms of ulcers on tongue, cheek, and lips, thickened gums, and white spots on mucosa and tongue.It was reported that bacteria developed under aligner and there was an infection in the patient's jaw and nerve, extending to the patient's right ear.The patient required visiting the emergency doctor at the hospital (where the doctor performed a root canal treatment), a dental hygienist, and later an orthodontist.The patient was prescribed with antibiotics from the root canal treatment, and the patient discontinued the use of the aligners on (b)(6) 2024.
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 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" and "tooth decay, periodontal disease, and permanent markings from stains and decalcification may occur if patients do not brush and floss their teeth properly during treatment or if they consume foods or beverages containing sugar while wearing aligners".No conclusive evidence has been provided that supports or opposes the fact that the invisalign aligners caused or contributed to the reported symptoms.This event is being filed as an mdr as the patient required medical intervention to prevent permanent damage, and the invisalign system aligners were being used.

• Brand Name: INVISALIGN SYSTEM
• 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: harper shore ; 2820 orchard parkway; san jose, CA 95134
• MDR Report Key: 19987704
• Report Number: 2953749-2024-02183
• Device Sequence Number: 17892948
• Product Code: NXC
• UDI-Device Identifier: 00816063020202
• UDI-Public: (01)00816063020202(10)0185787476(13)240527(91)2408001603N
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2024

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: INVISALIGN SYSTEM LITE
• Device Catalogue Number: 9002
• Device Lot Number: 185787476
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2024
• 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: Required Intervention
• Patient Age: 19 YR
• Patient Sex: Female