Since this event involved three medical devices, three manufacturer reports are being submitted.This report describes the second device.Manufacturer report numbers 3005174370-2015-00064 and 9611385-2015-00027, describe the first and third device, respectfully.
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On august 19, 2015, a dentist reported that a patient required endodontic treatment of tooth #14.This tooth had a crown made from 3m espe lava ultimate cad/cam restorative for cerec, which was seated with 3m espe relyx ultimate cement and 3m espe scotchbond universal adhesive on (b)(6) 2014.The crown debonded on (b)(6) 2014, and was re-cemented; at the time of re-cementation, the patient noted percussion sensitivity.On (b)(6) 2015, the patient reported that sensitivity was still present and the recommendation for endodontic treatment was made; treatment was performed on (b)(6) 2015.
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