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 Insufficient Information (3190)

Patient Problems Discomfort (2330); Sensitivity of Teeth (2427)

Event Date 04/07/2014

Event Type  Injury  

Manufacturer Narrative

The other 13 patient-specific events provided by this office are being reported separately.Since this event involved three medical devices, three manufacturer reports are being submitted.This report describes the first device.Manufacturer report numbers 9611385-2015-00069 and 9611385-2015-00070, describe the second and third device, respectively.

Event Description

On (b)(6) 2015, a representative from the dental office provided patient-specific information; initially, this office indicated "a couple" of patients required root canal treatment.In total, the office has now provided information on 15 root canals involving 14 patients.This report details a (b)(6) male patient who received a crown made from 3m espe lava ultimate cad/cam restorative for cerec on tooth #2 on (b)(6) 2013.This crown was secured with 3m espe relyx ultimate adhesive resin cement and 3m espe scotchbond universal adhesive.On (b)(6) 2014, the patient reported that he was experiencing pressure and temperature sensitivity; he was referred for endodontic treatment.The endodontic procedure was performed on (b)(6) 2014.The patient's status is currently reported as fine.

• 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 ; 6517331179
• MDR Report Key: 5206242
• MDR Text Key: 30581533
• Report Number: 3005174370-2015-00100
• 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: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• 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
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2052-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR