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 Codes	Pain (1994); Tooth Loss (4831)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The current instructions for use contain the following: "teeth that have been previously traumatized or significantly restored may worsen.In rare cases, the useful life of the tooth may be reduced, and the tooth may require additional dental treatment such as endodontic therapy and/or additional restorative treatment, and/or the tooth may be lost.".Potential root cause not identified.Align's clinical review of available records indicates that the retainer was reported as not fitting properly over tooth #19, and the patient experienced pain in that area.There is no conclusive evidence provided that supports or opposes whether the vivera retainer caused or contributed to the reported symptoms or the required tooth extraction.Based on the available information and the clinical assessment below, the treating doctor reported that the patient required tooth extraction, and the vivera retainers 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 had symptoms of pain when biting on tooth #19 and an ill fitting retainer over tooth #19.The patient's as tooth #18 was extracted.It is unknown if the patient was prescribed or took any medications to alleviate the reported symptoms.It is unknown if the patient discontinued or continued use of the retainers, and the patient's current condition is unknown.

• 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 parkway; san jose, CA 95134
• MDR Report Key: 24240245
• Report Number: 2953749-2026-00267
• Device Sequence Number: 9220827
• Product Code: DYT
• UDI-Device Identifier: 00816063020110
• UDI-Public: (01)00816063020110(10)0236750175(13)251017(91)2286713901R
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• 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: 8579
• Device Lot Number: 236750175
• 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: 01/05/2026
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2025
• 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: 44 YR
• Patient Sex: Female