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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 E4D MATERIAL, TOOTH SHADE, RESIN

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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 04/14/2016
Event Type  Injury  
Manufacturer Narrative
Based on the information provided, it is not known what role, if any, the lava ultimate played in the reported outcome. Other factors, such as the prior tooth history, may have contributed to the need for root canal therapy.
 
Event Description
On september 28, 2016, a dental professional reported that a (b)(6) male patient required root canal therapy on tooth #19. This tooth had a lava ultimate cad/cam restorative for e4d crown seated on (b)(6) 2013, because the patient's tooth had fractured. On (b)(6) 2016, the patient's lava ultimate crown fractured and decay was identified beneath; a root canal was performed.
 
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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 Key6065120
MDR Text Key58700497
Report Number3005174370-2016-00128
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 09/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2016
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 Received09/28/2016
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: 10/28/2016 Patient Sequence Number: 1
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