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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-HT
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Based on the limited information available for this case, it is not clear what role, if any, the use of lava ultimate may have had in the reported outcome.Other patient factors, such as prior tooth history, may have played a role in the need for tooth extraction.
 
Event Description
On (b)(6) 2016, a dental professional reported the case of a patient (age and gender not provided) who required extraction of tooth #19.This tooth is reported to have a lava ultimate cad/cam restorative for cerec crown, but no further information on the date of seating, date of failure or tooth history was provided.
 
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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
6517331179
MDR Report Key6176107
MDR Text Key62427491
Report Number3005174370-2016-00151
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 11/15/2016
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 Number2914A2-HT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/15/2016
Initial Date FDA Received12/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unknown
Removal/Correction NumberZ-2052-2015
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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