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

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 03/07/2019

Event Type  Injury  

Event Description

I wanted to share the following observation with regards to a pt that was orthodontically treated by the direct-to-consumer dental services company, smiledirectclub.A pleasant (b)(6) male presented to me for orthodontic consult on (b)(6) 2019 in (b)(6).He currently serves in the military.He had clear aligner with smiledirectclub to improve his crowding and close some gaps between his teeth.However, according to pt, smile direct club treatment resulted in several issues with his bite and jaw joint (tmj) pain.He said he cannot bite on his back teeth, only on his front teeth.He also mentioned that during the treatment, he developed pops and clicks in his jaw with occasional pain on chewing, and these symptoms are still present.On my clinical exam, i noted that his teeth are not properly fitting, his back teeth are open (posterior openbite) and there is heavy occlusal contact on his front teeth.The posterior openbite is severe on the right side.His second molars were touching very lightly on low hanging palatal cusps.From his smil edirect club account, he showed me digital impressions and videos of how his teeth were at the start and how the treatment was expected to progress.To correct his bite issues and improve his bite condition.I recommended full fixed appliances for the duration of 12 months.He would likely need to wear elastics to help settle his bite as well as conservative self-care therapy to alleviate tmj issues.According to ada policy adopted on october 2018, "ada strongly discourages the practice of direct to the consumer (dtc) dental lab services because of the potential for irreversible harm to pts." american association of orthodontists (aao) is concerned that smiledirectclub's alleged practices are, and will, result in harm to the public.The warnings from the professional associations should be taken seriously.These are "harms" that me and my colleagues are increasingly observing among pts in our communities.When close supervision by a licensed dentist is circumvented, harm can happen to pts.When proper steps such as oral and periodontal examinations, radiographic examinations, treatment planning and periodic progress assessments are ignored during orthodontic treatment, the potential for harm increases.Fda safety report id# (b)(4).

• Brand Name: SMILEDIRECTCLUB ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC. / SMILEDIRECT CLUB
• MDR Report Key: 8615688
• MDR Text Key: 145481400
• Report Number: MW5086674
• 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: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 24 YR