MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH 3M ESPE RELYX UNICEM 2 AUTOMIX; CEMENT, DENTAL

Catalog Number 56846

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Type  No Answer Provided  

Event Description

On (b)(6) 2014, 3m espe was contacted by a dentist who reported that following usage of the 3m espe product, 3m espe relyx unicem 2 automix.Three pts required endodontic treatment.Two pts had root canal treatments before and had to have them re-done.No other products were used aside from 3m espe relyx unicem 2 automix.

Manufacturer Narrative

Exact data on the symptoms which led to the necessity of the root canal treatments were not given by the dentist.The facts that the problems occurred in three different pts and no other complaints have reached us regarding the affected lot-no 551668 makes it doubtable that there are underlying allergic reactions or material defects.As it wasn't possible to gather more info from the doctor's office until the time of this report, it can't be determined if a handling error was the reason for the adverse events.3m espe relyx unicem 2 automix has been assessed for biocompatibility and has been found to be safe for its intended use.

• Brand Name: 3M ESPE RELYX UNICEM 2 AUTOMIX
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; neuss ; GM
• Manufacturer Contact: carl-schurz-strasse 1; neuss 41453 ; 9815270013
• MDR Report Key: 4222954
• MDR Text Key: 21877141
• Report Number: 9611385-2014-00013
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100756
• 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: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 56846
• Device Lot Number: 551668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2014
• Initial Date FDA Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention