Model Number INVISALIGN SYSTEM - MODERATE |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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No conclusive evidence has been provided that supports or opposes the fact that the invisalign system aligners caused or contributed to the reported symptom.This event is being filed as an mdr as the patient reported losing a tooth while an align product was being used.
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Event Description
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The patient reported the symptom of necrosis on tooth #4 (lower right 2nd premolar), which was extracted.The patient did not report requiring medical intervention to alleviate the reported symptoms.The patient did not report taking or being prescribed medication to alleviate the reported symptoms.The treatment has not been discontinued as the patient is still wearing the aligners.
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Search Alerts/Recalls
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