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 2017-03-09 for LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC 2914A2-LT manufactured by 3m Espe Dental Products.

Event Text Entries

[69554835] On the basis of the information provided, it is not known what role, if any, lava ultimate played in the reported outcome. Other factors, such as the prior tooth history of fracture, may have played a role in the need for the reported tooth extraction.
Patient Sequence No: 1, Text Type: N, H10


[69554836] On (b)(6) 2017, a dentist reported that a male patient ((b)(6)) required extraction of tooth #2. This tooth had a lava ultimate crown seated on (b)(6) 2012, because of an existing fracture noted in the tooth. On (b)(6) 2017, the crown debonded and secondary caries were discovered. At this time, the marginal integrity of the tooth was noted as poor. Subsequently, an extraction on this tooth was performed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005174370-2017-00023
MDR Report Key6393441
Report SourceHEALTH PROFESSIONAL
Date Received2017-03-09
Date of Report2017-02-15
Date of Event2017-01-13
Date Mfgr Received2017-02-15
Date Added to Maude2017-03-09
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 Phone6517331179
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 Received2017-03-09
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 2017-03-09

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