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

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

Patient Problem Convulsion/Seizure (4406)

Event Date 02/03/2023

Event Type  Injury  

Event Description

Eight days after starting invisalign clear braces, our son suffered his first ever tonic colonic seizure.He was put on the maintenance medication, keppra.While wearing the invisalign braces, he had an eeg which showed activity in the brain when triggered by light and exertion.He continued to wear the invisalign as directed.On (b)(6) 2023, he suffered a second seizure.Since that date, he has discontinued wearing invisalign and has been seizure free.

• Brand Name: INVISALIGN CLEAR BRACES
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 17080430
• MDR Text Key: 316809409
• Report Number: MW5118238
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 06/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: KEPPRA, 500 MG.
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White