Since this event involved three medical devices, three manufacturer reports are being submitted.This report describes the second device.Manufacturer report numbers 3005174370-2015-00075 and 9611385-2015-00042, describe the first and third device, respectively.
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On (b)(6) 2015, a dentist reported that two patients required root canal treatment.These patients had crowns made from 3m espe] lava ultimate cad/cam restorative for ts150, which were secured with 3m espe scotchbond universal adhesive and 3m espe relyx ultimate adhesive resin cement.No patient-specific information regarding the dates of product placement or treatment were provided to 3m espe despite multiple attempts to obtain such information.
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