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Device Problems
Stretched (1601); Material Too Soft/Flexible (4007)
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Patient Problems
Hemorrhage/Bleeding (1888); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/26/2020 |
Event Type
Injury
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Event Description
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I used the smile direct club invisible aligners.These are made very cheaply and get soft in your mouth quickly stretching.They are tight initially and move your teeth slightly but then get soft so your teeth move back, each consecutive pair did this for me so the next pair made my teeth move even more significantly not gradually because they had returned to their initial position.This caused bad pain and multiple teeth to become loose and wiggle.Also bleeding occurred in my top right incisor.I was given 3 re-evaluations/new sets of aligners, the product never fixed the initial issue with my teeth (a small gap in the front) and changed my bite so my molars cannot touch/chew.Fda safety report id# (b)(4).
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Search Alerts/Recalls
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