MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC; MATERIAL, TOOTH SHADE RESIN

Catalog Number	2914A2-LT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 prior tooth history and dental treatments, may have played a role in the need for the reported root canal treatment.
Event or Problem Description
On (b)(6) 2018, a dental assistant reported the case of a (b)(6) year old male patient who required root canal treatment on tooth #3.This tooth had a lava ultimate crown seated on (b)(6) 2014.On (b)(6) 2016, it was noted this tooth had discoloration at margin.No visible ledge or overhang was noted.The dental assistant reported the tooth appeared discolored and soft in the area the crown debonded.Decay, as a result of micro leakage, was noted into the pulp chamber which had caused the patient discomfort.As a result, root canal treatment was performed on that same day and an additional tooth structure was removed requiring a new crown to be placed.

• Brand Name: LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC
• Common Device Name: MATERIAL, TOOTH SHADE RESIN
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; 2510 conway avenue; st. paul MN 55144 1000
• MDR Report Key: 7476896
• Report Number: 3005174370-2018-00003
• Device Sequence Number: 11043965
• Product Code: EBF
• UDI-Device Identifier: 30605861040977
• UDI-Public: 30605861040977
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110131
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Dentist
• Device Catalogue Number: 2914A2-LT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/01/2018
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2052-2015
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR