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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hair Loss (1877); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Anxiety (2328); Numbness (2415); Cognitive Changes (2551); Suicidal Ideation (4429)

Event Date 01/01/2021

Event Type  Injury  

Event Description

Patient called to report how her invisible aligner has severely affected her mental and physical health for the past two years.The week that she received the aligners, she placed them on her teeth.After a few hours, she experienced excruciating pain throughout her face and head to the point that she had to remove them from her mouth.After removal she continued to experience pain and about one week later noticed a bony growth in her mouth.Patient went to see a doctor about it and was given antibiotics and was advised to have it (bony growth) removed.She spoke with the company that she purchased her aligners from and was told that they "forgot to trim" them.Patient says that she now has daily migraines, numbness in her face, concentration problems, short-term memory loss and is experiencing hair loss.Since then, she has not been able to work and has daily stress, anxiety and social interaction difficulties (mostly with family).Patient has had feelings and ideas of suicide in the recent past but no active plans or desires right now.She does feel "that she will not live much longer," because of the daily pain that she is dealing with.

• Brand Name: SMILE DIRECT ALIGNER
• Type of Device: ALIGNER SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 16910185
• MDR Text Key: 314980528
• Report Number: MW5117438
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Female