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

Catalog Number 56890

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 05/27/2014

Event Type  Injury  

Manufacturer Narrative

This event involved three medical devices, three manufacturer reports are being submitted.This report describes the second device.Manufacturer report numbers 3005174370-2015-00097 and 9611385-2015-00064, describe the first and third device, respectively.

Event Description

On (b)(6) 2015, a representative from the dental office provided patient-specific information; initially, this office indicated "a couple" of patients required root canal treatment.In total, the office has now provided information on 15 root canals involving 14 patients.This report details a (b)(6) female patient who received a crown made from 3m espe lava ultimate cad/cam restorative for cerec on tooth #3 on (b)(6) 2013.This crown was secured with 3m espe relyx ultimate adhesive resin cement and 3m espe scotchbond universal adhesive.On (b)(6) 2013, the patient reported pain; the crown was adjusted.On (b)(6) 2013, the patient again reported jaw pain and pressure sensitivity; the crown was re-adjusted.On (b)(6) 2014, the soft tissue adjacent to the crown was swollen and the patient reported pain; she was referred for endodontic treatment.The endodontic procedure was performed on (b)(6) 2014 and the crown re-cemented on (b)(6) 2014.The patient's status is reported as fine.

• Brand Name: RELYX ULTIMATE ADHESIVE RESIN CEMENT
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; carl-schurz-strabe 1; neuss, 41453 ; GM 41453
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH-SEEFELD; espe platz; seefeld, D8222 9; GM D82229
• Manufacturer Contact: thomas meindl ; carl-schurz-strabe 1; neuss, 41453 ; GM 41453
• MDR Report Key: 5196479
• MDR Text Key: 30204435
• Report Number: 9611385-2015-00063
• 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: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 56890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR