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

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 05/08/2019

Event Type  Injury  

Event Description

This pt is currently in treatment with aligner from smile direct club and is currently wearing the last set of aligners.He has a history of previous orthodontic treatment due to extractions done while he was in the military; #6 is badly ankylosed (ver clear on the percussion test and on a panoramic x-ray) and there is zero clinical mobility either.There are still spaces at #4/6, 12/14 and 19/21.Through the medical history, it was determined that a block segment was attempted for #6 in the past with no luck and there was extreme difficulty in closing the spaces with the ankylosis and elapsed time from the extractions.There is a noted upward cant for the upper anterior teeth and there was movement attempted on the canine with the aligners (but is clearly not fitting in that area).There are numerous areas of moderate gingival recession (and the trays were digging into a few areas which is not helping.There is noted bruxism habit and the trays are very heavily worn.Right now the aligners are doing more harm than good.This is treatment below the standard of care.I have supporting photographs of the iatrogenic problems cause by aligner treatment in this pt.No diagnostic records such as a panoramic x-ray or dental history was obtained prior to aligner therapy.Please feel free to contact me if you would like further documentation.I have photos, a panoramic x-ray as well as a detailed dental history to document the substandard care.Fda safety report id# (b)(4).

• Brand Name: SMILE DIRECT CLUB ORTHODONTIC ALIGNERS
• Type of Device: ALIGNER SEQUENTIAL
• Manufacturer (Section D): SMILEDIRECTCLUB / ALIGN TECHNOLOGY, INC.
• MDR Report Key: 9213761
• MDR Text Key: 163151840
• Report Number: MW5090487
• 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: Dentist
• Type of Report: Initial
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 48 YR
• Patient Weight: 84