Additional reports will be made for the other patients with lava ultimate crowns in this practice who required tooth extraction.This event involved four medical devices, four manufacturer reports are being submitted.This report describes the third device.Manufacturer report numbers 3005174370-2015-00095, 9611385-2015-00059 and 9611385-2015-00061, describe the first, second and fourth 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 october 7, 2015, detailed the case of a (b)(6) female patient who received a lava ultimate cad/cam restorative for cerec crown on tooth #30 secured with 3m espe scotchbond universal adhesive, 3m espe relyx ultimate adhesive resin cement and 3m espe relyx unicem 2 cement on (b)(6) 2012.No information was provided to indicate how the decay under the crown was identified; the office notes that the decay was to an extent that the tooth was not salvageable.The tooth was extracted on (b)(6) 2015.
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