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U.S. Department of Health and Human Services

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

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SMILEDIRECTCLUB / ALIGN TECHNOLOGY, INC. INVISIBLE ALIGNERS; ALIGNER, SEQUENTIAL Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Pain (1994); Swelling (2091); Discomfort (2330)
Event Date 02/15/2019
Event Type  Injury  
Event Description
This is in regards to my teeth alignment issue with (b)(6).I visited one of their bay area branches in (b)(4) on (b)(6) 2019.I wanted to reduce flaring protrusion on my upper anterior teeth with their invisible aligners to be worn for six months (180 days) as per their advertisement.Their store rep took the 3d photos of my teeth and signed me up on the same day.I requested that i need the sdc's orthodontist analysis report rx on those images before they charge my credit card and mail me the aligners.However, on the following day ((b)(6) 2019) i got their email stating that i was signed up right away, with invisible aligners being created.That email mentioned about custom-made aligners as per treatment plan but they had not provided me any such plan and they charged my credit card.They sent me the invisible aligners within a week on (b)(6) 2019 and still didn't provide the sdc's orthodontist report.I presumed i could use those aligners as their sdc's orthodontist must have evaluated and designed them based on my needs.Close to the end of 90 days, i was unable to wear the aligners due to severe pain and had to book an appt with sdc at the same redwood city location.The pain began from the week 2 ((b)(6) 2019) of starting to wear the aligners and persisted all throughout the 90 day treatment period.I had to bear the pain thinking that it was an innate component of sdc's treatment process.When i went back for 90 days progress evaluation after using their aligners, their rep said that the correction of protrusion is not possible and the aligners were just meant to reduce the gap between teeth.Sdc customer support also emailed me the same.I had to go through so much of pain day and night for those 90 days using sdc aligners which i thought would orthodontically repositioned and eliminate flaring in my upper anteriors and thus would achieve a straight edge to edge bite.I was never told before beginning treatment that the purpose i desired could not be achieved with sdc aligners and sdc's treatment plan rx.I couldn't even bite an apple all those days because of the pain and sensitivity those aligners created on to my teeth.After going through all these inconvenience of wearing pain producing aligners for 90 days for no orthodontic benefit.Due to sdc's false promise and the delay in providing me the info that the reduction in flared upper anteriors to create a straight edge to edge bite cannot be achieved.I asked them to cancel further procedures.I also had dental crowns on some of my teeth which underwent root canal treatment before.Because of the friction, pain and realignment of my teeth with the use of sdc invisible aligners, one of my dental caps also fell off and i had to approach a dentist to fix that tooth but my gums were swollen and became sensitive.When i consulted an orthodontist later, he said the falling off of my existing crown was probably due to those aligners.In addition, he told me that the severe pain and discomfort i went through for 3 months with sdc treatment plan is not something which would happen with a methodological correction when an orthodontist is involved who would take close observation throughout the treatment period.No dentist monitored me during the three months i suffered with sdc's treatment aligners which i now have learned were doomed to fail and they did fail.Sdc's mail order aligners provided the wrong treatment plan and treatment.The correct treatment required an orthodontist's training, knowledge and hands on treatment.Sdc's mail order aligners did not and could not ever provide correct orthodontic treatment because no sdc dentist ever examined or treated me in person to design the correct orthodontic treatment and monitor its progress.Sdc's treatment was useless, a waste of my time, painful and no bargain.Fda safety report id# (b)(4).
 
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Brand Name
INVISIBLE ALIGNERS
Type of Device
ALIGNER, SEQUENTIAL
Manufacturer (Section D)
SMILEDIRECTCLUB / ALIGN TECHNOLOGY, INC.
MDR Report Key9234429
MDR Text Key164082758
Report NumberMW5090617
Device Sequence Number1
Product Code NXC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
Patient Age37 YR
Patient Weight68
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