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

Model Number	1011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	02/01/2026
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.".No root cause provided.Align's clinical review found that records from may 2023 indicated the only missing tooth at that time was lr4.Available photographic records suggested that this tooth previously supported a dental crown.The patient underwent several treatment plans showing minimal planned movement of lr4.Based on the patient's report, a bone graft and future implant placement indicated that lr4 required extraction prior to these procedures.There is no conclusive evidence provided that supports or opposes whether the invisalign retainer caused or contributed to the reported disability or permanent damage.Based on the available information, the patient had disability or permanent damage, and the invisalign retainer 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 event, and the date (b3) is based on the timelines reported to align and compared to patient information.
Event or Problem Description
The patient reported symptoms of one dental crown becoming completely dislodged, including the pin securing it, and a second crown becoming damaged while attempting to seat or remove an invisalign retainer.The patient reported visiting the treating doctor and required medical intervention consisting of replacement of the broken crown, a bone graft, and a future implant placement, meaning that the patient at some point lost a tooth.No additional information is available at this time.Attempts to obtain additional information about the event were unsuccessful.

• Brand Name: INVISALIGN 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: 24597429
• Report Number: 2953749-2026-00873
• Device Sequence Number: 9605961
• Product Code: DYT
• UDI-Device Identifier: 00816063020011
• UDI-Public: (01)00816063020011(10)0175521017(13)240209(91)1228990101R
• 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,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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: 1011
• Device Lot Number: 175521017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2024
• 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: Disability
• Patient Age: 62 YR
• Patient Sex: Female