• 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 CEREC; 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 CEREC; MATERIAL, TOOTH SHADE, RESIN Back to Search Results
Catalog Number 2914A2-LT
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 04/07/2016
Event Type  Injury  
Manufacturer Narrative
Based on the available information, it is not known what role, if any, lava ultimate played in the reported patient outcome.Other factors, such as prior tooth history or other dental treatments, may have played a role in the need for tooth extraction.
 
Event Description
This case was identified through post-market surveillance activities.Records provided by the dental professional indicated that this female patient (age or date-of-birth were not provided) required extraction of tooth #19.This tooth had received a lava ultimate crown on (b)(6) 2013, because the prior restoration on the tooth had open margins.In addition, this tooth had undergone root canal treatment at some prior point.On (b)(6) 2013, the lava ultimate crown was adjusted because of sensitivity.On (b)(6) 2015, the patient reported a dull ache in the area around this tooth; notes indicate that the dentist believed this was due to soft tissue issues because of the pre-existing root canal.On (b)(6) 2016, the crown was noted as loose; it was removed, decay was identified and the tooth was extracted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC
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
MDR Report Key6458691
MDR Text Key71682652
Report Number3005174370-2017-00035
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 03/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dentist
Device Catalogue Number2914A2-LT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Removal/Correction NumberZ-2052-2015
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-