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

Model Number	1011
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	04/01/2025
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.".After clinical analysis if the mentioned adverse event (mobility that will end in tooth loss #9) it is noted on initial records that the mentioned tooth had a pre-existing buccal recession and swollen gingiva, same as tooth #10 and #11.No initial x-rays were submitted to evaluate the alveolar bone, periodontal ligament among other structures.When the treating doctor was asked how is the event related to the use of the product they answered: retainers were too tight.No conclusive evidence has been provided that supports or opposes whether the invisalign system aligners caused or contributed to the required a tooth extraction (permanent damage) and the invisalign system aligners 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 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 patient presents tooth mobility and will require tooth extraction of tooth #9.No additional information is available at this time.

• Brand Name: INVISALIGN 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: 21920625
• Report Number: 2953749-2025-00965
• Device Sequence Number: 8907647
• Product Code: DYT
• UDI-Device Identifier: 00816063020011
• UDI-Public: (01)00816063020011(10)0195481577(13)240904(91)2151465501R
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 04/28/2025

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: 195481577
• 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: 04/22/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2024
• 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: 60 YR
• Patient Sex: Female