Although this report has not been confirmed by a medical professional, it is being reported as the loss of a dental filling or tooth is considered to be a serious injury.However, dental experts conclude that a healthy tooth or dental restoration could not be cracked or pulled loose by the use of dental floss alone, and that underlying and pre-existing dental disease or a compromised dental restoration would be the root cause of the event.This is a known issue with dental floss.Note: this report is the result of a communication between the manufacturer and the fda's medical device policy branch where clarification was given regarding adverse event reportability.This resulted in a two-year retrospective review for reportable events in order to identify and submit all events meeting the criteria described by the fda's representative.In closing out the capa, it was noted that this report has been missed.
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