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

Catalog Number 56858

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Missing Value Reason (3192)

Event Type  Injury  

Manufacturer Narrative

Exact data on the symptoms which led to the necessity of the root canal treatments were not given by the dentist.As described above it was found out that a handling error led to 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.Device was not sent to us.

Event Description

On (b)(6) 2016, a dentist reported that several patient required root canal treatment after the use of 3m espe relyx unicem 2 automix.These patients had crowns made from the competitor material e.Max cad from ivoclar vivadent.In an interview with the dentist it showed that there's underlying an application error.The dentist overdried during the application which led to pain symptoms and subsequent to the root chanel treatments.

• Brand Name: 3M ESPE RELYX UNICEM 2 AUTOMIX
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; carl-schurz-strabe 1; neuss, 41453 ; GM 41453
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH-SEEFELD; espe platz; seefeld, 82229 ; GM 82229
• Manufacturer Contact: thomas meindl ; carl-schurz-strabe 1; neuss, 41453 ; GM 41453
• MDR Report Key: 5575067
• MDR Text Key: 42606333
• Report Number: 9611385-2016-00004
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 56858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention