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

Model Number	8579
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	06/19/2026
Type of Reportable Event	Serious Injury
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 treating doctor shared that the tooth prognosis was good.The tooth was not expected to be extracted or lost during treatment.Treating doctor doesn't know if treatment plan could have aggravated the clinical condition.Align's clinical review noted that the patient underwent two rounds of aligner therapy, with the first consisting of 15 upper and 18 lower aligners and the second consisting of 18 aligners.The initial treatment plan demonstrated uneven occlusal contacts prior to treatment, including heavier contact on tooth #5.Following the first round, occlusal contacts were redistributed, with reduced contact on tooth #5.The final programmed occlusion showed generally even contacts posteriorly, with the exception of teeth lacking antagonists.Tooth #5 did not undergo moderate or complex movements during treatment.The patient initially presented with a posterior open bite, which treatment aimed to correct.The most recent record showing the tooth present and reportedly healthy was dated (b)(6) 2025.No radiographic records were available to further assess the condition of the tooth.There is no conclusive evidence provided that supports or opposes whether the vivera retainer caused or contributed to the reported permanent damage.Based on the available information, the patient had permanent damage, and the vivera retainer were being used.Therefore, an mdr will be filed in the united states per 21 cfr 803.The exact date of the event is unknown.Despite reasonable efforts, no conclusive information was available to determine when the event occurred.The date (b3) provided corresponds to the date the event was reported to the manufacturer and does not necessarily reflect the actual date of occurrence.
Event or Problem Description
The treating doctor reported that the patient had symptoms of tooth loss involving tooth #5.The patient did not report requiring any medical intervention as a result of the event.The patient indicated taking antibiotics to alleviate the reported symptoms.The patient is continuing treatment with the vivera retainers and is currently asymptomatic.

• Brand Name: VIVERA RETAINER
• 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: 25693096
• Report Number: 2953749-2026-02209
• Device Sequence Number: 15813363
• Product Code: DYT
• UDI-Device Identifier: 00816063020110
• UDI-Public: (01)00816063020110(10)0234088562(13)250923(91)2405255201R
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/02/2026

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: 234088562
• 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: 06/19/2026
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2025
• 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: 36 YR
• Patient Sex: Male