Patient specific information was not provided.Product lot and serial # information was not provided.Product lot # information was not provided.Manufacture date is unknown.: the dental office indicated patient-specific information would be provided to 3m to assist in the investigation; however, to date, this information has not been made available.No product samples were returned for evaluation; thus, engineering evaluation of the actual product is limited.Based on the limited information provided to 3m on this case, it is unclear what role, if any, the lava ultimate restoration may have played in the reported outcome.Other factors, such as prior tooth history, patient factors or dental treatments, may have played a role in the reported need for root canal treatment.
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On (b)(6) 2018, a dentist reported to 3m that some of his patients who had lava ultimate crowns placed between 2012 through 2015 required root canal therapy because of decay beneath the crown.The dentist did not provide a specific number of cases that have occurred, the dates on which the root canals took place or other information to assist in the investigation of this report (such as the type of cement used to seat the crown).The dentist states he believes he followed correct placement protocol.
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