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 09/12/2011

Event Type  Injury  

Manufacturer Narrative

It is not known what role, if any, the 3m cement may have played in this reported outcome.Other factors, such as prior tooth history, patient factors or dental treatment, may have played a role in the need for root canal therapy.Relyx luting cement has a highly favorable clinical usage history and has been shown to be safe for its intended use.

Event Description

On (b)(6) 2017, a dentist reported that a male patient required a root canal (affected tooth number not provided).On (b)(6) 2010, 3m espe relyx luting luting cement was used to place a crown.Approximately one year later, the patient saw an endodontist who suggested that the patient had pulpitis that was likely due to a potential allergy to the cement.The root canal was performed on (b)(6) 2011.

• 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: 6404691
• MDR Text Key: 69945812
• Report Number: 3005174370-2017-00026
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K933139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• 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: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention