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

Model Number	VIVERA RETAINERS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Tooth Fracture (2428); Tooth Loss (4831)
Date of Event	09/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported directly to align the following symptoms: bite issues, tmj, and a molar on the upper left arch fell out when flossing (or a piece of the patient's tooth).The patient required visiting a second dentist, who filled the gap so the tooth root was not exposed and who diagnosed the patient with tmj.The patient reported taking muscle relaxers to alleviate the reported symptoms.
Additional Manufacturer Narrative
The reported symptoms are included in the current instructions for use (ifu).The treating doctor shared that the patient had not reported anything about losing a tooth or a piece of a tooth.The treating doctor mentioned that the patient was given a night guard (not an align device) and that all of the patient's teeth were occluding well.Align's clinical review of available records indicate that the event could have only included a restoration to avoid root exposure, indicating that the tooth´s root was still present in buccal cavity.No conclusive evidence has been provided that supports or opposes whether the vivera retainers caused or contributed to the reported tooth extraction or whether a tooth extraction occurred, and therefore this event is being filed as an mdr per 21 cfr 803.There is no conclusive evidence to confirm the date of the reported tooth extraction, and the date of event (b3) is based on the timelines reported to align and compared to the patient information.

• 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: harper shore ; 2820 orchard parkway; san jose, CA 95134
• MDR Report Key: 20400900
• Report Number: 2953749-2024-02754
• Device Sequence Number: 3579233
• Product Code: DYT
• UDI-Device Identifier: 00816063020110
• UDI-Public: (01)00816063020110(10)0172341148(13)240108(91)09155806XXR
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2024

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: VIVERA RETAINERS
• Device Catalogue Number: 8579
• Device Lot Number: 172341148
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2024
• 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: 30 YR
• Patient Sex: Female