Based on the information provided by the patient, there is no conclusive evidence that supports or opposes the fact that the aligners caused, contributed, or would likely cause or contribute to the reported event.This event is being filed as an mdr since the patient reported symptoms or physiological conditions related to tooth infection which the customer stated resulted in extraction of the tooth.
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The customer reported an infection on tooth #3 while wearing the aligners.Medical intervention was required, an extraction was performed.It is unknown if aligner treatment was discontinued.For this event, the patient identifier is (b)(6)and the complaint number is (b)(4).
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