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 Type  Injury  

Manufacturer Narrative

Based on the available information, it is not known what role, if any, the relyx luting cement may have played in the reported outcome.Other factors, such as the crown margin being too close to the bone level, may have caused the pain experienced by the patient, which resulted in the crown lengthening procedure and root canal.

Event Description

On (b)(6) 2016, a dentist reported that a (b)(6) female required a root canal procedure on tooth # 29.This tooth had a crown (brand unknown) seated on (b)(6) 2016 with 3m espe relyx luting cement.The dentist reported that a crown lengthening procedure was also performed in addition to the root canal.

• 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: 6345042
• MDR Text Key: 67810991
• Report Number: 3005174370-2017-00007
• 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: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• 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: 01/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR