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

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 11/07/2019

Event Type  malfunction  

Event Description

I received three aligners from smile direct club that obviously are the prescription of another pt's.Upon opening my sealed (and correctly labeled) aligner package.I noticed that the aligners were not of my own teeth - they clearly being to another pt.Three packages, all sealed and correctly labeled with my name and qr code, were not mine.I contacted smile direct club, and they told me to wait for several weeks (through a long backlog) until i receive correct aligners, to resume my treatment.I was also told to continue wearing the aligners i am currently wearing, which are intended to have a wear life of only 2 weeks, until i receive the correct aligners.The incorrect aligners were for month3week1, month3week2, and month 3week3-4.Fda safety report id# (b)(4).

• Brand Name: PLASTIC TEETH ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.
• MDR Report Key: 9328490
• MDR Text Key: 166810178
• Report Number: MW5091103
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 52