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 05/22/2023 |
Event Type
Injury
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Event Description
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The customer reported bone loss and recession while wearing the aligners,the customer was not able to provide the impacted tooth number.Medical intervention was required, and an extraction was performed.The treatment was discontinued.For this event, the patient identifier is (b)(6)
and the complaint number is (b)(4).
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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 tbone loss and gum recession which the customer stated resulted in extraction of the tooth.
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Search Alerts/Recalls
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