MAUDE Adverse Event Report: SMILEDIRECTCLUB /ALIGN TECHNOLOGY, INC. NIGHTTIME ALIGNER KIT; ALIGNER, SEQUENTIAL

Device Problems Loss of or Failure to Bond (1068); Product Quality Problem (1506); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2020

Event Type  malfunction  

Event Description

I purchased a 24-aligner kit from smiledirectclub.Com.The 8th aligner in the series (bottom piece) did not adhere to the teeth correctly.In response to my request for a remedy (on (b)(6) 2019), i was sent a complete set of 24 new aligners (arriving (b)(6) 2020).The aligner #8 from that set was fine.For aligner #9, i tried to go back to the original set, but it also fit poorly.Returning to the second set, i made it all the way to aligner #11 (on (b)(6) 2020).When i opened the aligner #11 packet, i found it contained two bottoms (instead of a bottom and a top).Both pieces were marked identically, and there was no way to tell which one might actually be next in the series.I checked the aligner #12 packet and found that this one had two tops, also marked identically, and with no way to distinguish them.Then i checked the aligner #13 packet.In this one, while there was both a top and a bottom, one of the tooth pockets had an obvious defect in the plastic, and there was no way it would fit properly over my teeth.I have substantial doubts that i will be able to cobble together a proper series of 24 aligners, even though i own two complete and independent sets.The quality level of this product is outside what a consumer should expect for a safe, precision tooth aligner.The considerable production delays suggest to me that smiledirectclub's quality control is under pressure.In addition, smiledirectclub has not contacted me with instructions on how to supply 90-day periodic check-in photos (needed to maintain their warranty), although i have not addressed the issue with them.As such, i have not sent any photos to them in relation to the 90- day checks, even though i began treatment on (b)(6) 2019.Fda safety report id# (b)(4).

• Brand Name: NIGHTTIME ALIGNER KIT
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILEDIRECTCLUB /ALIGN TECHNOLOGY, INC.
• MDR Report Key: 9933967
• MDR Text Key: 187101853
• Report Number: MW5094065
• Device Sequence Number: 2
• 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: 04/03/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 70