MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS RELYX LUTING LUTING CEMENT; DENTAL CEMENT

Catalog Number 3505

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 01/18/2016

Event Type  Injury  

Manufacturer Narrative

Since there were two medical devices involved in this event, two manufacturer reports are being submitted.This report contains information about the second device.Manufacturer report 300517-2017-00001 contains information about the first device.Based on available information, it is not known what role, if any, the lava ultimate crown or the relyx luting cement may have played in this reported patient outcome.Other factors, such as prior tooth history or dental treatment, may have played a role in the need for root canal therapy.3m espe relyx luting cement has a highly favorable clinical usage history and in the last 8 years, 3m has not received any other reports of root canals in patients whose restorations were secured with this product.

Event Description

On (b)(6) 2016, a dental professional reported the case of a patient (age and gender not provided to 3m) who required root canal therapy on tooth #31.This tooth had a lava ultimate cad/cam restorative for e4d crown placed on (b)(6) 2013, because a prior restoration in that tooth had caries beneath it.The crown was seated with 3m espe relyx luting cement, a product which is not intended to be used with lava ultimate.On (b)(6) 2016, the patient received root canal treatment.

• Brand Name: RELYX LUTING LUTING CEMENT
• Type of Device: DENTAL CEMENT
• 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: 6224221
• MDR Text Key: 63910988
• Report Number: 3005174370-2017-00002
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K933139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 3505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention