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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 12/30/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, a dealer representative informed 3m espe that a dental professional who used 3m espe lava ultimate cad/cam restorative for e4d, 3m espe scotchbond universal adhesive and 3m espe relyx ultimate cement had recommended and endodontic procedure to one of his patients.Upon follow-up directly with the dental professional, a male patient presented with mirco-leakage and an abscess on tooth #3 which had a crown placed one year prior, on (b)(6) 2013.The dentist recommended endodontic treatment, but has not heard back from his patient.

Manufacturer Narrative

There were three suspect devices involved in this events.If any new information about this event becomes available to 3m espe, a follow-up report will be submitted.This report describes the first suspect device.Manufacturer report numbers 3005174370-2015-00011 and 3005174370-2015-00012 provide information on the second and third suspect devices involved in this event, respectively.

• Brand Name: 3M ESPE LAVA ULTIMATE CAD/CAM RESTOR. FOR E4D
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; st. paul MN
• Manufacturer Contact: 2510 conway avenue; st. paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 4459572
• MDR Text Key: 5403864
• Report Number: 3005174370-2015-00010
• 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,Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR