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

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

Patient Problems Headache (1880); Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146)

Event Date 06/18/2017

Event Type  Injury  

Event Description

I used sdc to correct some.Mild anterior mandibular crowding under the impression that my bite would remain the same from the 3rd images.After following the full 9 month 20 tray course, i was left with a seriously open posterior bite to where nearly couldn't chew.I had jaw pain, migraines and burning in my jaw at times.Sdc told me there was nothing they could do about my ruined bite.They deleted all my files so i can't even show you what i had versus what they predicted and what my ortho is now correcting.Fda safety report id# (b)(4).

• Brand Name: SMILE DIRECT CLEAR ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILE DIRECT / ALIGN TECHNOLOGY, INC.
• MDR Report Key: 8582503
• MDR Text Key: 144259618
• Report Number: MW5086386
• 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: 05/01/2019

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 94