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

Catalog Number 2914A2-LT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 01/24/2017

Event Type  Injury  

Manufacturer Narrative

This manufacture report is for the second of two individual patient cases identified in manufacturing report 3005174370-2016-00041 follow-up 1.Based on the available information, it is not known what role, if any, the lava ultimate restorative material played in this reported outcome.Other factors, such as prior tooth history and dental treatments, may have played a role in the need for root canal treatment.

Event Description

On (b)(6) 2017, a dental professional reported the case of a female patient ((b)(6)) who required root canal treatment on tooth #13.This tooth had a lava ultimate crown placed on (b)(6) 2015, due to the existing crown having recurrent decay beneath it.On (b)(6) 2017, the patient reported hypersensitivity.At this time, the tooth was noted as having poor marginal integrity and discoloration.Subsequently, root canal treatment was performed, core build up done, and a non-3m crown placed.

• Brand Name: LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC
• 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: angie draper ; 2510 conway avenue; st. paul, MN 55144-1000
• MDR Report Key: 6458684
• MDR Text Key: 71683389
• Report Number: 3005174370-2017-00034
• Device Sequence Number: 1
• Product Code: EBF
• 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: 03/10/2017

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
• Device Operator: Dentist
• Device Catalogue Number: 2914A2-LT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: Z-2052-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention