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Catalog Number 41258 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Sensitivity of Teeth (2427)
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Event Type
Injury
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Event Description
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On (b)(6) 2015, a dental professional reported to 3m espe that some of his patients required endodontic treatment to relieve persistent sensitivity experienced after placement of 3m espe lava ultimate cad/cam restorative for e4d.The dentist was unable to provide any further detail on the number of patients involved or the dates on which these endodontic treatments were performed.Companion products used to secure the crowns were 3m espe relyx ultimate cement and 3m espe scotchbond universal adhesive, as well as other non-3m espe cements.Since this event involved three medical devices, three mfr reports are being submitted.
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Manufacturer Narrative
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3m espe rec'd this report on (b)(6) 2015, and has attempted to obtain more specific information.However, because the reported events happened sometime between 2011 and 2015 and because the dentist was not willing or able to provide additional information, patient-specific reporting is not possible.This report describes the third device.Mfr report numbers 3005174370-2015-00042 and 3005174370-2015-00043 describe the first and second device, respectfully.
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Search Alerts/Recalls
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