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 04/01/2022 |
Event Type
Injury
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Event Description
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The patient reported symptoms of abscess on ul 6 after the start of 1st aligner and had to be extracted to avoid future complications.The reported symptom does not appear to be serious or life threatening to the patient.The patient did not report requiring any medical intervention to alleviate the reported symptom.The patient reported being prescribed antibiotics to alleviate the reported symptom.The patient is continuing the use of the aligners and is currently getting better.The potential root cause is unknown.
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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.A udi could not be provided in this report as this information was not captured in this complaint ticket.
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Search Alerts/Recalls
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