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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Sensitivity of Teeth (2427)

Event Date 11/11/2019

Event Type  Injury  

Event Description

Smile direct club aligners caused by tooth to begin dying.Tooth became loose and painful for many weeks prior.There was no info regarding my condition and was repeatedly told it was normal.I researched and searched for weeks regarding what was going on with my tooth before it finally began to turn colors.Two dentists have diagnosed my tooth as dying.My options are to have a root canal or have the tooth pulled.It is a front tooth.Each dentist has told me they have seen multiple pts with a similar condition.Date of use: (b)(6) 2019 - (b)(6) 2019.Reason for use: overbite and crowding.Did the problem stop after the person stopped using the product? no; did the problem return if the person started using the product again? didn't restart.Fda safety report id# (b)(4).

• Brand Name: INVISIBLE ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.
• MDR Report Key: 9341055
• MDR Text Key: 167039960
• Report Number: MW5091143
• 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: 11/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Weight: 54