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

Catalog Number 3114A2-LT

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Sensitivity of Teeth (2427)

Event Type  Injury  

Manufacturer Narrative

The 3m espe received this report on july 9, 2015, and has attempted to obtain more specific info.However, because the reported events happened sometime between 2011 and 2015 and because the dentist was not willing or able to provide add'l info, pt-specific reporting is not possible.

Event Description

On (b)(6) 2013, a dentist reported that some of his pts had need for endodontic treatment.These pts had dental restorations made from 3m espe lava ultimate cad/cam restorative for e4d, which were seated with 3m espe relx ultimate cement and 3m espe scotchbond universal adhesive.The reporting dentist indicated that approx 240 of his pts experienced sensitivity.The dentist was unable to provide a number for those requiring endodontic treatment because the events occurred over a period of several years (2011 to 2015).Since this event involved three medical devices, three mfr reports are being submitted.This report describes the first device.Mfr report numbers 9611385-2015-00006 and 9611385-2015-00007, describe the second and third device, respectfully.

• Brand Name: LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; st. paul MN
• Manufacturer Contact: 2510 conway avenue; saint paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 4995046
• MDR Text Key: 22825593
• Report Number: 3005174370-2015-00046
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Remedial Action: Recall
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3114A2-LT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: RECALL #Z-2052-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other