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

Catalog Number 2914A2-LT-S

Device Problems Migration or Expulsion of Device (1395); Nonstandard Device (1420)

Patient Problem No Code Available (3191)

Event Date 05/07/2013

Event Type  Injury  

Event Description

On (b)(6) 2015, a dentist reported that a (b)(6) male patient required endodontic treatment on tooth #4 on (b)(6) 2013.This tooth had an onlay made from 3m espe lava ultimate cad/cam restorative for cerec which was placed on (b)(6) 2012.Prior to placement of the lava ultimate onlay, the tooth was reported to have had a large filling with decay underneath it.The dentist reported that the onlay had leaked and resulted in the need for a root canal.

• 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: 5371621
• MDR Text Key: 36213743
• Report Number: 3005174370-2016-00014
• 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: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 2914A2-LT-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2015
• 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
• Patient Age: 33 YR