Since there were two medical devices involved in this event, two manufacturer reports are being submitted.Section of this report contains information about the second device.Section of manufacturer report 300517-2017-00003 contains information about the first device.Based on the available information, it is not known what role, if any, the lava ultimate crown or the relyx luting luting cement may have played in this reported patient outcome.Other factors, such as prior tooth history or dental treatment, may have played a role in the need for root canal therapy.The 3m espe relyx luting luting cement has a highly favorable clinical usage history and in the last 8 years, 3m has not received any other reports of root canals in patients whose restorations were secured with this product.
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On (b)(6), 2016, a dental professional reported the case of a patient (age and gender not provided to 3m) who required root canal therapy on tooth #30.This tooth had a crown made from lava ultimate restorative placed on (b)(6) 2013, because a prior restoration on that tooth had caries beneath it.The crown was seated with 3m espe relyx luting luting cement, a product which is not intended to be used with lava ultimate.On (b)(6) 2015, the patient received the root canal treatment through the lava ultimate crown.
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