Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/11/2022 |
Event Type
Injury
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Event Description
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The customer reported gum recession and tooth mobility on teeth #24, #25, #3 and #19 while wearing the aligners.Medical intervention is required, and bone and gum grafts will be performed.Aligner treatment was discontinued.For this event, the patient identifier is (b)(4) and the complaint number is (b)(6).
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Manufacturer Narrative
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Based on the information provided by the patient, 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 related to a tooth mobility and gum recession.
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Search Alerts/Recalls
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