MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH RELYX ULTIMATE ADHESIVE RESIN CEMENT

Catalog Number 56890

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Sensitivity of Teeth (2427)

Event Type  Injury  

Manufacturer Narrative

3m espe rec'd this report on july 14, 2015 and has attempted to obtain more specific information.However, because the reported events happened sometimes between 2013 and 2015 and because the dentist was not willing or able to provide additional information, patient-specific reporting is not possible.Since this event involved three medical devices, three manufacturer reports are being submitted.This report describes the second device.Mfr report numbers 3005174370-2015-00048 and 9611385-2015-00009, describe the first and third device, respectfully.

Event Description

A dentist reported that 2-3 patients had need for endodontic treatment.These patients had dental restorations made from 3m espe lava ultimate cad/cam restorative for cerec, which were seated with 3m espe relyx ultimate cement and 3m espe scotchbond universal adhesive.The reporting dentist indicated that leakage at the margin led to caries under the crown.Because the events occurred during the time period of 2013 to 2015, no further patient-specific information was available.

• Brand Name: RELYX ULTIMATE ADHESIVE RESIN CEMENT
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; neuss ; GM
• Manufacturer Contact: carl-schurz-strabe 1; neuss 41453 ; 9815270013
• MDR Report Key: 4990597
• MDR Text Key: 23381963
• Report Number: 9611385-2015-00008
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 56890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other