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

Catalog Number 56890

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Code Available (3191)

Event Date 03/03/2013

Event Type  Injury  

Event Description

3m espe learned that a customer who had a full coverage crown made from lava ultimate required endodontic treatment.The crown was placed on (b)(6) 2012.On (b)(6) 2012 the crown was debonded and was re-cemented with 3m espe relyx ultimate cement.The patient was seen on (b)(6) 2013, and at that time, a recommendation for endodontic treatment was made; treatment was executed on (b)(6) 2013.No further info is available regarding patient status or on specific lots of product used.

Manufacturer Narrative

This report arises from a recent retrospective review of records.There were two devices involved in this event.This report describes the second device and mfr report number 3005174370-2015-00029 provides info on the first device involved in this event.

• Brand Name: RELYX ULTIMATE ADHESIVE RESIN CEMENT
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; seefeld ; GM
• Manufacturer (Section G): ESPE PLATZ; seefeld ; GM
• Manufacturer Contact: carl-schurz-strasse 1; neuss 41453 ; 9815270013
• MDR Report Key: 4761792
• MDR Text Key: 5787960
• Report Number: 3005174370-2015-00030
• 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,Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• 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: 04/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention