Model Number INVISALIGN SYSTEM - COMPREHENSIVE |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2021 |
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 tooth loss (permanent impairment to body structure) and the invisalign product was being used.
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Event Description
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The patient reported tooth 4.7 (lower right 2nd molar) was extracted.It is unknown if the patient required medical intervention to alleviate the reported symptoms.It is unknown if the patient took or was prescribed medication to alleviate the reported symptoms.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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