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

Catalog Number 2914A1-LT

Device Problems Failure To Adhere Or Bond (1031); Nonstandard Device (1420)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

Since this event involved three medical devices, three manufacturer reports are being submitted.Section of this report describes the first device.Section of manufacturer report numbers 9611385-2015-00031 and 9611385-2015-00032, describe the second and third device, respectively.

Event Description

On (b)(6) 2015, a dentist reported that a (b)(6) female patient requires endodontic treatment of tooth #4.This tooth had a crown made from 3m espe lava ultimate cad/cam restorative for cerec, which was seated with 3m espe relyx ultimate cement and 3m espe scotchbond universal adhesive on (b)(6) 2013.The crown debonded on (b)(6) 2015, and the patient reported temperature and pressure sensitivity.The patient is scheduled for endodontic treatment on (b)(6) 2015.

• 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: 5104630
• MDR Text Key: 26787171
• Report Number: 3005174370-2015-00069
• 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
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 2914A1-LT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2015
• 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: 60 YR