INVISIBLE ALIGNER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-24 for INVISIBLE ALIGNER manufactured by Smile Direct Club/ Align Technology, Inc..

Event Text Entries

[176628153] I have completed a total of three (3) treatment sessions with smile direct club (sdc), including two (2) reevaluations as recommended by the licensed treating doctor. A semi- annual routine checkup was conducted was conducted today by my primary orthodontist, and there is some concern regarding a malocclusion resulting in a misaligned bite and jaw pain. The product was also manufactured in such a way that the aligner continuously cut into the gums. On several occasions, i have requested communication with the licensed treating doctor assigned to my treatment plan. I have yet to have any communication with the licensed professional since the beginning of my treatment in (b)(6) 2018. I have contacted sdc regarding this matter and my concerns, but i am not receiving direct communication from the licensed professional that resides in another state. The only from of communication that i have been involved in is with the customer service representatives. The last communication with sdc was on (b)(6) 2019, and i have not heard back since this date. As mentioned above, i now have additional concerns after visiting with my primary orthodontist. It appears that the treatment has ended with a malocclusion and further misalignment of the teeth, jaw, and overall bite. The only solution proposed from the sdc team is to have the licensed doctor reevaluate my case. As mentioned above, i have previously completed two (2) reevaluations in which the outcomes were similar and sdc did not address the concerns or issues that were initially agreed upon at the beginning of my treatment plan.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092488
MDR Report Key9631822
Date Received2020-01-24
Date of Report2020-01-14
Date of Event2020-01-14
Date Added to Maude2020-01-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINVISIBLE ALIGNER
Generic NameALIGNER, SEQUENTIAL
Product CodeNXC
Date Received2020-01-24
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSMILE DIRECT CLUB/ ALIGN TECHNOLOGY, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.