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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sensitivity of Teeth (2427)
Date of Event	10/15/2019
Event or Problem Description
Pt has been in smile direct club aligners for the past 12 months, he presented with complaints that his bite was not right and he was hitting on his front teeth very hard.Upon exam, his maxilla is overexpanded, and he has traumatic occlusion on his anterior teeth.He displays mobility on upper incisors.Fda safety report id# (b)(4).

• Brand Name: SMILEDIRECTCLUB ALIGNERS
• Common Device Name: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.
• MDR Report Key: 9208029
• Report Number: MW5090468
• Device Sequence Number: 10667691
• Product Code: NXC
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR