MAUDE Adverse Event Report: SMILEDIRECTCLUB S.A. ALIGNERS; ALIGNER, SEQUENTIAL

Device Problem Output Problem (3005)

Patient Problems Failure of Implant (1924); Choking (2464)

Event Description

I got smile direct club aligners in 2020.Part way through the treatment, my aligners failed to fit so i got "touch ups", a new set of aligners.I did this process twice.At one point i was given dental advice over the phone by a tech to "just try a different set" instead of referring me to a licensed orthodontist.Toward the end of the two rounds my molars failed to match, making it difficult to chew food.Once i stopped wearing the aligners for 22hrs a day i found myself choking on food as i adjusted to the gaps in my molars.Since then i've tried to get sdc to rectify the problem with no meaningful support.My primary care dentist and sdc techs have both attested to the gaps in my bite but i've received no support for the damages done.Sdcs negligence during and after treatment could cost me thousands of dollars and adverse health effects in the future (can get my dentist to attest to the change in my bite if documents are helpful).

• Brand Name: ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILEDIRECTCLUB S.A.
• MDR Report Key: 15249363
• MDR Text Key: 298395801
• Report Number: MW5111546
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/17/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1