Based on the information provided by the patient and internal investigation conducted by access dental lab, 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 that describe tooth chipping.Reported outside of the 30 day reporting window due to updated reporting requirements (capa-(b)(4)).
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The customer reported that aligners caused pain, and a tooth chipped.A dentist evaluated the customer; however, no surgical intervention has been done yet.As a result, the customer discontinued the use of aligners.
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