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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

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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 01/23/2017
Event Type  Injury  
Manufacturer Narrative
This manufacture report is for the first of two individual patient cases identified in manufacturing report 3005174370-2016-00041 follow-up 1.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 root canal treatment.
 
Event Description
On (b)(6) 2017, a dental professional reported the case of a female patient ((b)(6)) who required root canal treatment on tooth #4.This tooth had a lava ultimate crown placed on (b)(6) 2013, because the pre-existing restoration had decay beneath it.On (b)(6) 2017, it was reported that the crown had fractured and secondary caries were discovered.Subsequently, root canal treatment was performed, core build up was done and a non-3m crown placed.
 
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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 Key6458670
MDR Text Key71683564
Report Number3005174370-2017-00033
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 03/10/2017
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 Number2914A2-LT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/10/2017
Initial Date FDA Received04/04/2017
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;
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