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

Catalog Number 56890

Device Problem Missing Value Reason (3192)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

3m espe received this report on july 30, 2015 and has attempted to obtain more patient-specific information.Since the dentist was not able to provide the additional information, patient-specific reporting is not possible.Since this event involved three medical devices, three manufacturer reports are being submitted.This report describes the second device.Manufacturer report numbers 3005174370-2015-00057 and 9611385-2015-00020, describe the first and third device, respectfully.

Event Description

On (b)(6) 2015, a dentist reported that some of his patients required endodontic treatment.These patients had restorations made from 3m espe lava ultimate cad/cam restorative for cerec, which were seated with 3m espe relyx ultimate cement and 3m espe scotchbond universal adhesive the dentist was unable to provide further patient-specific details on the cases requiring the endodontic treatment other than most were for crowns and were placed prior to (b)(6) 2014.

• 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, d82229; seefeld, D8222 9; GM D82229
• Manufacturer Contact: thomas meindl ; carl-schurz-strabe 1; neuss, 41453 ; GM 41453
• MDR Report Key: 5036903
• MDR Text Key: 24354587
• Report Number: 9611385-2015-00019
• 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: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• 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: 07/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other