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

Device Problems Patient Device Interaction Problem (4001); Lack of Effect (4065)

Patient Problem Pain (1994)

Event Date 06/04/2018

Event Type  Injury  

Event Description

Invisalign didn't straighten snaggle tooth as show in computer video and left me with an open bite.I couldn't eat or bite into food or chew normally.It took years for my teeth to slowly move back into a position i could live with.I had terrible pain in my left jaw and neck when eating.I could eat only soft foods for about 2 years.It costs about (b)(6) for what turned out to be torture.Dentist should not sell invisalign to older patients and should be thoroughly trained in invisalign treatments.

• Brand Name: INVISALIGN
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 16584139
• MDR Text Key: 311817848
• Report Number: MW5115880
• 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: 03/18/2023

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?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White