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 12/23/2022 |
Event Type
Injury
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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 that describe tooth mobility which the customer stated resulted in an implantation treatment.
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Event Description
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The customer reported reported mobility on an upper front tooth while wearing the aligners, the customer was not able to provide the impacted tooth number.Medical intervention is required, and an implant will be performed.It is unknown if aligner treatment was discontinued.For this event, the patient identifier is cbc98922a949b0 and the complaint number is id-269283.
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Search Alerts/Recalls
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