During a follow-up to retrieve the product for evaluation, it was discovered that the handpiece was recently repaired by a non-dentsply sirona repair facility and the doctor returned it to that facility.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.A dhr review was conducted with no discrepancies noted.
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