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

Catalog Number 56890

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 12/30/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, a dealer representative informed 3m espe that a dental professional who used 3m espe lava ultimate cad/cam restorative for e4d, 3m espe scotchbond universal adhesive and 3m espe relyx ultimate cement had recommended and endodontic procedure to one of his patients.Upon follow-up directly with the dental professional, a male patient presented with mirco-leakage and an abscess on tooth #3 which had a crown placed one year prior, on (b)(6) 2013.The dentist recommended endodontic treatment, but has not heard back from his patient.

Manufacturer Narrative

There were three suspect devices involved in this event as described.If any new information about this event becomes available to 3m espe, a follow-up report will be submitted.This report describes the third suspect device.Manufacturer report numbers 3005174370-2015-00010 and 3005174370-2015-00011 provide information on the first and second suspect devices involved in this event, respectively.

• Brand Name: 3M ESPE RELYX ULTIMATE AUTOMIX CEMENT
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; neuss ; GM
• Manufacturer (Section G): ESPE PLATZ; seefeld D822 29; GM D82229
• Manufacturer Contact: carl-schurz-strabe 1; neuss 41453 ; 9815270013
• MDR Report Key: 4459570
• MDR Text Key: 5327093
• Report Number: 3005174370-2015-00012
• 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: 12/30/2014

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: Health Professional
• Device Catalogue Number: 56890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2014
• Initial Date FDA Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR