MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS RELY ULTIMATE ADHESIVE RESIN CEMENT; DENTAL CEMENT

Catalog Number 56890

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Since this event involved three medical devices, three manufacturer reports are being submitted.Section of this report describes the second device.Section of manufacturer report numbers 3005174370-2015-00071 and 9611385-2015-00036, describe the first and third device, respectively.

Event Description

On (b)(6) 2015, a dentist reported that a patient required a root canal.This tooth had a crown made from 3m espe lava ultimate cad/cam restorative for cerec which was seated on (b)(6) 2014, using 3m espe relyx ultimate cement and 3m espe scotchbond universal adhesive.During the week of (b)(6) 2015, the patient presented with pain and upon removal of the crown, recurrent decay too extensive to allow for restoration was noted and the patient was referred for endodontic treatment.

• Brand Name: RELY ULTIMATE ADHESIVE RESIN CEMENT
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; 2510 conway avenue; st. paul MN 55144 1000
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH-SEEFELD; espe platz, d82229; seefeld, D8222 9; GM D82229
• Manufacturer Contact: thomas meindl ; carl-schurz-strabe 1; neuss, 41453 ; GM 41453
• MDR Report Key: 5116972
• MDR Text Key: 27219115
• Report Number: 9611385-2015-00035
• 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
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• 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: 09/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR