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

Patient Problems Dyspnea (1816); Fatigue (1849); Headache (1880); Pain (1994); Anxiety (2328); Cramp(s) /Muscle Spasm(s) (4521); Joint Contracture (4528)

Event Date 03/09/2022

Event Type  Injury  

Event Description

I began invisalign treatment in 2021.The goal of this treatment was to correct my anterior open bite and improve my oral health.Unfortunately, it led to temporomandibular joint disorder (tmd) in (b)(6) 2022, as diagnosed by multiple medical professionals.This condition is chronic, annoyingly disruptive, and detrimentally impairs my daily functions and overall quality of life.I firmly believe that these complications were caused by the aligners, themselves - which i was instructed to wear for at least 20 to 22 hours per day by my orthodontist.Throughout the treatment, i found myself inadvertently clenching my jaw to cope with this foreign object in my mouth - followed by frequent muscle spasms/tension.Additionally, i experienced extreme fatigue, headaches, neck pain, anxiety, and difficulty breathing at times, which, in hindsight, i believe were clear indicators from my body that something was amiss.

• Brand Name: INVISALIGN
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY INC.
• MDR Report Key: 18544198
• MDR Text Key: 333384617
• Report Number: MW5150542
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: NTI (NOCICEPTIVE TRIGEMINAL INHIBITION TENSION SUPPRESSION SYSTEM) SPLINT, PRESCRIBED BY ORTHODONTIST - TO ALLEVIATE SOME OF MY CURRENT SYMPTOMS.
• Patient Outcome(s): Other; Disability
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Race: White