LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D N/A 3114A2-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 2018-12-26 for LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D N/A 3114A2-LT manufactured by 3m Espe Dental Products.

Event Text Entries

[131470607] Patient specific information was not provided. Product lot and serial # information was not provided. Product lot # information was not provided. Manufacture date is unknown. : the dental office indicated patient-specific information would be provided to 3m to assist in the investigation; however, to date, this information has not been made available. No product samples were returned for evaluation; thus, engineering evaluation of the actual product is limited. Based on the limited information provided to 3m on this case, it is unclear what role, if any, the lava ultimate restoration may have played in the reported outcome. Other factors, such as prior tooth history, patient factors or dental treatments, may have played a role in the reported need for root canal treatment.
Patient Sequence No: 1, Text Type: N, H10


[131470608] On (b)(6) 2018, a dentist reported to 3m that some of his patients who had lava ultimate crowns placed between 2012 through 2015 required root canal therapy because of decay beneath the crown. The dentist did not provide a specific number of cases that have occurred, the dates on which the root canals took place or other information to assist in the investigation of this report (such as the type of cement used to seat the crown). The dentist states he believes he followed correct placement protocol.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005174370-2018-00007
MDR Report Key8197998
Report SourceHEALTH PROFESSIONAL
Date Received2018-12-26
Date of Report2018-12-26
Date of Event2018-11-28
Date Mfgr Received2018-11-28
Date Added to Maude2018-12-26
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 ContactMS. SUZANNE LEUNG
Manufacturer Street2510 CONWAY AVENUE BUILDING 275-02-W-08
Manufacturer CityST. PAUL MN 551441000
Manufacturer CountryUS
Manufacturer Postal551441000
Manufacturer Phone6515758052
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 E4D
Generic NameMATERIAL, TOOTH SHADE, RESIN
Product CodeEBF
Date Received2018-12-26
Model NumberN/A
Catalog Number3114A2-LT
Lot NumberN/A30605861041233
OperatorHEALTH PROFESSIONAL
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 2018-12-26

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