Additional reports will be made for the other patients with lava ultimate crowns in this practice who required tooth extraction.Since this event involved three medical devices, three manufacturer reports are being submitted.This report describes the second device.Manufacturer report numbers 3005174370-2015-00094 and 9611385-2015-00058, describe the first and third device, respectively.
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On (b)(6) 2015, a representative from a dental office reported that patients with 3m espe lava ultimate cad/cam restorative crowns required tooth extraction.Follow-up information provided by the office on (b)(6) 2015, detailed the case of a (b)(6) female patient who received a lava ultimate cad/cam restorative for cerec crown on tooth #31 secured with 3m espe scotchbond universal adhesive and 3m espe relyx unicem 2 cement on (b)(6) 2012.The patient experienced sensitivity upon pressure/biting and a root canal procedure was performed on (b)(6) 2012.On (b)(6) 2015, the office indicated that a tooth extraction was performed for this tooth, but no further details about the events that led to this treatment were provided.
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