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

Catalog Number 56890

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Dentist reported that following the use of 3m espe lava ultimate cad/cam restorative, 3m espe relyx, ultimate adhesive resin cement and (b)(6) adhesive to prepare and seat full coverage crowns, a patient required extraction of the treated tooth because of an infection in the root canals.Following the extraction and replacement with an implant and crown, the symptoms resolved.No 3m espe products were used in the replacement procedure.The dentist does not recall specifically what tooth was involved in this case; it may have been tooth 14 or 15.

Manufacturer Narrative

There were three devices involved in this event.Manufacturer report numbers 3005174370-2015-00024 and 3005174370-2015-00026 provide information on the first and third device involved in this event, respectfully.

• Brand Name: RELYX ULTIMATE CEMENT
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; neuss ; GM
• Manufacturer Contact: carl-schurz-strasse 1; neuss 41453 ; 8152700132
• MDR Report Key: 4660174
• MDR Text Key: 5610201
• Report Number: 3005174370-2015-00025
• 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
• Type of Report: Initial
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2015
• 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: 03/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Other