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

Model Number	INVISALIGN SYSTEM - LITE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
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".The treating doctor shared that the potential root cause of this event could have been the aligner use and the tooth preexistent condition, and shared possible patient's noncompliance.The patient required a tooth extraction (permanent impairment of a body structure), and the invisalign system aligners were being used, and therefore this event is being filed as an mdr per 21 cfr 803.There is no conclusive evidence to confirm the date of the required tooth extraction, and the date (b3) is based on the timelines reported to align and compared to the patient information.
Event or Problem Description
The treating doctor reported that the patient's tooth 3.1/ll1 had to be extracted.This tooth developed an abscess during invisalign treatment and required endodontic treatment, but the condition of the tooth got worse, and the tooth had to be extracted.

• 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: adriana solis ; 2820 orchard parkway; san jose, CA 95134
• MDR Report Key: 20697629
• Report Number: 2953749-2024-03330
• Device Sequence Number: 15075242
• Product Code: NXC
• UDI-Device Identifier: 00816063020202
• UDI-Public: (01)00816063020202(10)0118147859(13)220510(91)12459436XXN
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/15/2024

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: 118147859
• 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: 10/19/2022
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2022
• 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: Female