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

[71682348] This manufacturer report is being submitted for the first of four individual patient cases identified in manufacturing report 3005174370-2016-00040 follow-up 1. Based on the available records, it is not clear what role, if any, the lava ultimate restoration, played in this event. Other factors, such as prior tooth history and dental treatments, may have played a role in the need for tooth extraction.
Patient Sequence No: 1, Text Type: N, H10


[71682349] This patient record was identified during post-market surveillance activities. Records supplied by the dental office indicate that a female patient (yob 1966) required extraction of tooth #30. This tooth had received a lava ultimate crown on (b)(6), 2012, because a prior crown had broken and was painful. On (b)(6) 2013, this tooth received root canal therapy (because the tooth was reported as "having throbbing pain" from the date of seating, a relationship to the use of lava ultimate is not established. The onset of symptoms at seating suggests that either pre-existing conditions or preparation trauma led to the need for the root canal. ) after the root canal, the same lava ultimate crown was re-seated. On (b)(6) 2015, the patient reported that the crown had debonded 3 days prior; she was experiencing some sensitivity and a periapical x-ray showed evidence of infection around the root. On (b)(6) 2015, an endodontist recommended that the tooth be extracted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005174370-2017-00029
MDR Report Key6457821
Report SourceHEALTH PROFESSIONAL
Date Received2017-04-04
Date of Report2017-03-08
Date of Event2015-07-10
Date Mfgr Received2017-03-08
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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