Tooth fracture and filling crown loss are well-documented issues when using dental floss.The loss of a crown can occur when a dental restoration that is unsound or at the end of it's life is subjected to the forces occurring during normal dental hygiene.The use of dental floss with an improperly restored tooth could exacerbate a pre-existing condition and cause unforeseen damage.Note: this report is being provided as a part of a retrospective review, per discussion with fda medical device policy branch, and was performed as a result of recent changes/improvements made to our mdr reporting system as a result of an internal audit.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 representative.
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