LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC 2914A2-LT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-04 for LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC 2914A2-LT manufactured by 3m Espe Dental Products.

Event Text Entries

[71683564] 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.
Patient Sequence No: 1, Text Type: N, H10


[71683565] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005174370-2017-00033
MDR Report Key6458670
Report SourceHEALTH PROFESSIONAL
Date Received2017-04-04
Date of Report2017-03-10
Date of Event2017-01-23
Date Mfgr Received2017-03-10
Date Added to Maude2017-04-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactANGIE DRAPER
Manufacturer Street2510 CONWAY AVENUE
Manufacturer CityST. PAUL MN 551441000
Manufacturer CountryUS
Manufacturer Postal551441000
Manufacturer G13M ESPE DENTAL PRODUCTS-IRVINE
Manufacturer Street2111 MCGAW AVENUE
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal Code92614
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberZ-2052-2015
Event Type3
Type of Report3

Device Details

Brand NameLAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC
Generic NameMATERIAL, TOOTH SHADE, RESIN
Product CodeEBF
Date Received2017-04-04
Catalog Number2914A2-LT
OperatorDENTIST
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer3M ESPE DENTAL PRODUCTS
Manufacturer Address2510 CONWAY AVENUE ST. PAUL MN 551441000 US 551441000


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-04-04

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