MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN SYSTEM; ALIGNER, SEQUENTIAL

Model Number	INVISALIGN FULL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Joint Dislocation (2374); Swelling/ Edema (4577)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported directly to align the following symptoms: dislocated jaw, jaw pain and swelling, shattered tmj joint, which required multiple tmj surgeries and resulted in a bacterial infection, bite issues, and continued jaw pain.The patient reported requiring medications for the bacterial (staph) infection, botox and physical therapy for tmj pain, in addition to the reported tmj surgeries and visits to the oral surgeon.The patient reported discontinuing the use of the aligners (date unknown).
Additional Manufacturer Narrative
The current instructions for use (ifu) contains the following: "precautions - in rare instances, problems in the temporo-mandibular joint (temporo-mandibular disorder (tmd)) may result in joint pain, headaches, or ear problems.During forward posturing and vertical changes with mandibular advancement features, problems in the temporo-mandibular joint may be exacerbated" and "the bite may change during treatment; this may result in temporary patient discomfort" and "at the end of treatment, the bite may require adjustment by the doctor".No conclusive evidence has been provided that supports or opposes the fact that the invisalign system aligners caused or contributed to the reported symptoms.This event is being filed as an mdr as the patient reported requiring surgical intervention to alleviate the reported tmj symptoms (serious injury), and the invisalign system aligners were being used.

• Brand Name: INVISALIGN SYSTEM
• Common Device Name: ALIGNER, SEQUENTIAL
• 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: 19563583
• Report Number: 2953749-2024-01688
• Device Sequence Number: 15347197
• Product Code: NXC
• UDI-Device Identifier: 00816063020004
• UDI-Public: (01)00816063020004(10)0062193792(13)200108(91)06814080XXN
• Combination Product (Y/N): N
• PMA/510(K) Number: K220287
• 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): 06/18/2024

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: INVISALIGN FULL
• Device Catalogue Number: 8500
• Device Lot Number: 62193792
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2020
• 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: 60 YR
• Patient Sex: Female