Palisades dental was notified on (b)(6) 2019 that a clinical incident occured sometime in (b)(6) 2018 as "the handpiece was used to section a tooth in the upper quadrant.The bur rotated within the chuck of the handpiece and dislodged.The patient had a rubber dam barrier in place, isolating the tooth and quadrant.The bur was retrieved without incident".Though no medical/surgical intervention was required to preclude a serious injury in this event, there have been previously reported events involving a similar device that resulted in the need for medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.Therefore, this event meets the criteria for reportability per 21 cfr part 803.Palisades dental performed an investigation and concluded that the failure is not manufacture related, rather related to the failure of following instructions for use.
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