Model Number INVISALIGN SYSTEM - COMPREHENSIVE |
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 having tooth # 31 (lower right 2nd molar) extracted.It is unknown if the patient required medical intervention to alleviate the reported symptom.It is unknown if the patient took or was prescribed medication to alleviate the reported symptom.It is unknown if the treatment has been discontinued or if the patient is still wearing the aligners.
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Search Alerts/Recalls
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