MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. VIVERA RETAINERS; MAINTAINER, SPACE PREFORMED, ORTHODONTIC

Model Number	8579
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Localized Skin Lesion (4542)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The treating doctor is reporting that the patient's tongue was injured and the lesion required to be removed via surgery.The patient required medical intervention and lab/test were performed but could not to be provided.The patient was prescribed with medications but they are unknown.Patient stopped the use of the product.When asked how is the patient doing by now treating doctor shared the following: after surgery patient's is good.
Additional Manufacturer Narrative
The current instructions for use contains the following: "precautions, health of the bone and gums which support the teeth may be impaired or aggravated.".When the treating doctor was asked how the event is related to the use of the product they answered: the doctor shared that the use of the vivera retainers.No conclusive evidence has been provided that supports or opposes whether the vivera retainers caused or contributed to the required surgery (required intervention to prevent permanent impairment or damage) and vivera retainers were being used.Therefore, an mdr will be filed in the united states per 21 cfr 803.There is no conclusive evidence to confirm the date of the required medical intervention to prevent an impairment or damage, and the date (b3) is based on the timelines reported to align and compared to patient information.

• Brand Name: VIVERA RETAINERS
• Common Device Name: MAINTAINER, SPACE PREFORMED, ORTHODONTIC
• 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 parway; san jose, CA 95134
• MDR Report Key: 21978457
• Report Number: 2953749-2025-01014
• Device Sequence Number: 7273038
• Product Code: DYT
• UDI-Device Identifier: 00816063020110
• UDI-Public: (01)00816063020110(10)0191856709(13)240726(91)1000821301R
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 05/07/2025

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: 8579
• Device Lot Number: 191856709
• 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: 04/24/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2024
• 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: 52 YR
• Patient Sex: Female