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

Device Problems Component Missing (2306); Device Misassembled During Manufacturing /Shipping (2912); Packaging Problem (3007)

Patient Problem Pain (1994)

Event Date 12/18/2019

Event Type  malfunction  

Event Description

The company is smile direct club.They have the aligners pre-packaged (one upper aligner and one lower aligner) by use date such as month 3/wk 2 for example.When i got to month 4/wk 2 i tried to put on the lower aligner and it caused a great deal of pain, it was not possible for me to wear.After a very long hold time i was able to speak someone at smile direct and they asked for the id number pre-printed on each aligner.It turns out that the upper aligner was correctly marked u11 but the lower aligner was marked l20 which means that it is to be used during month 7/wk 2.The rep from smile direct said something to the effect of "no big deal", just switch ahead to your month 4/wk 3 and 4 aligners.I decided to go ahead and open all remaining packages to check the remaining packages and not only did i finally locate the correct l11 in a different package, i also discovered several other packaging errors.For example, in my month 6/wk 2 package i found (2) upper aligners and (0) lower aligners.I found other duplicates but in the end after sorting everything i found that i was left with no m5/w2 lower aligner and also the same for my m6/w2.I reached out to smile direct several times without ever getting a call back.Just this week i finally got hold of a person and she advised me to just go ahead and move forward.I asked if that is okay, why did we even get aligners packaged like they were.Her response was that it's not the best situation but you will never get your replacements in time.We are telling people that it takes 5-6 wks to get replacements.I have friends who have waited up to (2) months for replacements.It seems to me that these aligners fall into the medical device category.Most people get 18-21 sets of aligners in individual labeled packages.I myself was assigned 7 months wear time which is 21 packages at (3) packages per month broke down into week 1, week 2, weeks 3 and 4.Of my 21 packages, (5) of the (15) packages that i checked (those unused) were packaged either incorrectly or were completely missing aligners.I believe that this company is just focused on fulfilling new customers and they are not in quality compliance.Fda safety report id# (b)(4).

• Brand Name: SMILE DIRECT CLUB ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 9601602
• MDR Text Key: 176018216
• Report Number: MW5092339
• 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: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• 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 Age: 53 YR
• Patient Weight: 86