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 Codes	Tooth Fracture (2428); Tooth Loss (4831)
Date of Event	11/05/2025
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 potential root cause of this event is unknown; however, the treating doctor indicated that occlusion changes during treatment may have contributed to the event.Align's clinical review of available records indicates that tooth #5 was noted to have a dental crown with visible signs of wear.The patient underwent two aligner treatment phases: the first consisting of 12 upper aligners, and the second of 4.No significant tooth movements were programmed for tooth #5 throughout the course of treatment.Scientific literature consistently indicates that teeth with both a root canal and a crown are structurally compromised, which places their long-term prognosis at risk.No conclusive evidence has been provided that supports or opposes whether the invisalign retainer caused or contributed to the reported tooth fracture and subsequent bridge placement extraction (permanent damage), 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 tooth extraction, and the date (b3) is based on the timelines reported to align and compared to patient information.
Event or Problem Description
The treating doctor reported that the patient had symptoms of tooth fracture requiring extraction and bridge placement.It is unknown if the patient required any additional medical intervention or medications to alleviate the reported symptoms beyond the prescribed tylenol.It is unknown if any clinical or laboratory tests were performed.

• 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: 23646500
• Report Number: 2953749-2025-02988
• Device Sequence Number: 10055235
• Product Code: DYT
• UDI-Device Identifier: 00816063020011
• UDI-Public: (01)00816063020011(10)0216895396(13)250408(91)2409207401R
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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: 1011
• Device Lot Number: 216895396
• 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: 11/05/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2025
• 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: 50 YR
• Patient Sex: Female