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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 11/28/2018

Event Type  Injury  

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 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
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; 2510 conway avenue; st. paul MN 55144 1000
• Manufacturer (Section G): 3M ESPE DENTAL PRODUCTS-IRVINE; 2111 mcgaw avenue; irvine CA 92614
• Manufacturer Contact: suzanne leung ; 2510 conway avenue; building 275-02-w-08; st. paul, MN 55144-1000 ; 6515758052
• MDR Report Key: 8197997
• MDR Text Key: 131470555
• Report Number: 3005174370-2018-00008
• Device Sequence Number: 1
• Product Code: EBF
• UDI-Device Identifier: 30605861041233
• UDI-Public: 30605861041233
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110131
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3114A2-LT
• Device Lot Number: N/A30605861041233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2052-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention