• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

3M ESPE DENTAL PRODUCTS LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D MATERIAL, TOOTH SHADE, RESIN Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D
Type of DeviceMATERIAL, 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 Key6205072
MDR Text Key63308806
Report Number3005174370-2016-00156
Device Sequence Number1
Product Code EBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110131
Number of Events Reported1
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
Date FDA Received12/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dentist
Device Catalogue Number3114A2-HT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage
Removal/Correction NumberZ-2052-2015

Patient Treatment Data
Date Received: 12/27/2016 Patient Sequence Number: 1
-
-