Since this event involved three medical devices, three manufacturer reports are being submitted.This report describes the second device.Manufacturer report numbers 3005174370-2015-00055 and 9611385-2015-00016, describe the first and third device, respectfully.
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On (b)(6) 2015, a dentist reported that a patient requires tooth extraction of tooth #19.This tooth had a crown made from 3m espe lava ultimate cad/cam restorative for cerec, which was seated with 3m espe scotchbond universal adhesive and 3m espe relyx ultimate cement.The patient was experiencing sensitivity and the crown was removed to perform a root canal.At that time, it was discovered that the canal had calcified and the only treatment option was to extract the tooth.Treatment is planned pending insurance information.The dentist was unable to definitively attribute this effect to the of lava ultimate as a crown material.
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