MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D; MATERIAL, TOOTH SHADE, RESIN

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 tooth extraction.
Event or Problem Description
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 tooth extraction because of decay beneath the crown.The dentist did not provide a specific number of cases that have occurred, the dates on which the extractions 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.

• Brand Name: LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D
• 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: 8197997
• Report Number: 3005174370-2018-00008
• Device Sequence Number: 233815
• Product Code: EBF
• UDI-Device Identifier: 30605861041233
• UDI-Public: 30605861041233
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 12/26/2018

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3114A2-LT
• Device Lot Number: N/A30605861041233
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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