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	01/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the limited information provided to 3m on this case, it is not clear what role, if any, the use of lava ultimate may have had in the reported outcome.Other patient factors, such as prior tooth history, patient factors and dental treatments, may have played a role in the need for the root canal therapy.
Event or Problem Description
On (b)(6) 2018, a dental office reported that five patients (ages and genders not provided) with a lava ultimate restoration required root canal treatment due to the discovery of recurrent decay.Further patient specific information on the date of seating, date of failure, and tooth history was not provided to 3m.

• 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: 7274214
• Report Number: 3005174370-2018-00001
• Device Sequence Number: 1043900
• 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): 02/13/2018

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: 01/22/2018
• Initial Report FDA Received Date: 02/15/2018
• 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