MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 3114A2-HT

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 03/02/2015

Event Type  Injury  

Manufacturer Narrative

Since there were two medical devices involved in this event, two manufacturer reports are being submitted.This report contains information about the first device.Manufacturer report 300517-2016-00157 contains information about the second device.Based on the available information, it is not known what role, if any, the lava ultimate restorative material played in this reported outcome.Other factors, such as prior tooth history and dental treatments, may have played a role in the need for the root canal.

Event Description

On (b)(6) 2016, a dental professional reported the case of a patient (age and gender not provided) who required root canal therapy on tooth #19.This tooth had received a 3m espe lava ultimate cad/cam restorative for e4d crown on (b)(6) 2014, on a tooth which had a prior restoration and decay beneath it.The crown was secured with a non-recommended cement type, 3m espe relyx luting cement.It was reported that on (b)(6) 2015, the patient required root canal therapy and replacement of the crown.

• Brand Name: LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; 2510 conway avenue; st. paul MN 55144 1000
• Manufacturer (Section G): 3M ESPE DENTAL PRODUCTS-IRVINE; 2111 mcgaw avenue; irvine CA 92614
• Manufacturer Contact: angie draper ; 2510 conway avenue; st. paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 6205072
• MDR Text Key: 63308806
• Report Number: 3005174370-2016-00156
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110131
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 3114A2-HT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: Z-2052-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention