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 loss of a tooth and an infection.This adverse event is being reported after 30 calendar days.During the evaluation of the complaint, it was found that the issue details was not timely created after becoming aware.
|
The customer reported an infection on a front upper tooth and loss of tooth #30 while wearing the aligners, the customer was not able to provide the impacted tooth number for the infection.Medical intervention was required, and a root canal and an extraction were performed.Aligner treatment was discontinued.For this event, the patient identifier is (b)(6) and the complaint number is (b)(4).
|