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

Model Number	VIVERA RETAINERS
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The current instructions for use (ifu) contains the following: "general risks to patients - in rare instances, problems in the temporo mandibular joint (jaw joint) may result in joint pain, headaches, or ear problems".The potential root cause of this event could have been the movement of the patient's teeth (as shared by the patient who was advised by the treating doctor).Align technology's clinical team has indicated the following: although the surgery type was not specified, tmj surgery is prescribed as a last resource for severe temporomandibular joint disorder for patients with intense pain, who cannot open or close the mouth all the way, have trouble eating or drinking due to difficult jaw mobility, and/or patients with specific structural problems or diseases in the jaw joint.This is confirmed radiologically with imaging, such as an mri (results from patient's mri are unknown).This event is being filed as an mdr as the patient reported requiring surgery to fix tmj (surgical intervention to prevent permanent damage) and the vivera retainers were being used.
Event or Problem Description
The treating doctor reported that the patient had symptoms of jaw pain due to movements in the teeth, which has now resulted in the need for the patient to undergo jaw surgery to fix tmj.The patient reported being referred to a specialist by the treating doctor however was unable to afford this and the patient, instead, reported visiting a pcp to alleviate the reported symptom.The patient reported being advised by the treating doctor to take muscle relaxers (otc) to alleviate the reported symptom.It is unknown if the patient is continuing the use of the retainers.
Additional Manufacturer Narrative
Catalog number corrected.

• 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 ; 3030 slater road; morrisville, NC 27560 ; 4084701343
• MDR Report Key: 18536156
• Report Number: 2953749-2023-03833
• Device Sequence Number: 7557725
• Product Code: DYT
• UDI-Device Identifier: 00816063020172
• UDI-Public: (01)00816063020172(10)0128272368(13)220907(91)0928687701R
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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: 128272368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/23/2023
• Supplement Date Received by Manufacturer: 12/23/2023
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• 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: Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female