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

Catalog Number 56890

Device Problems Loss of or Failure to Bond (1068); Material Integrity Problem (2978); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 06/18/2015

Event Type  Injury  

Manufacturer Narrative

Since this event involved three medical devices, three manufacturer reports are being submitted.This report describes the third device.Manufacturer report numbers 3005174370-2015-00049 and 9611385-2015-00010, describe the first and second device, respectfully.

Event Description

A dentist reported that one of her patients required extraction of tooth #29.This patient had a crown placed on (b)(6) 2014, made from 3m espe lava ultimate cad/cam restorative for e4d, which was seated with 3m espe scotchbond universal adhesive and 3m espe relyx ultimate cement.On (b)(6) 2015, it was noted that leakage had occurred resulting in secondary caries; because the tooth had rec'd endodontic treatment in the past (details not provided to 3m espe), the caries progressed undetected to a point where extraction was the only treatment option.The patient will receive an implant.

Manufacturer Narrative

This report describes the second device.Manufacturer report numbers 3005174370-2015-00049 and 9611385-2015-00011, describe the first and third device, respectfully.

Event Description

A dentist reported that one of her patients required extraction of tooth #29.This patient had a crown placed on (b)(6) 2014, made from 3m espe lava ultimate cad/cam restorative for cerec, which was seated with 3m espe relyx ultimate cement and 3m espe scotchbond universal adhesive.On (b)(6) 2015, it was noted that leakage had occurred resulting in secondary caries; because the tooth had received endodontic treatment in the past (details not provided to 3m espe), the caries progressed undetected to a point where extraction was the only treatment option.The patient will receive an implant.

• Brand Name: RELYX ULTIMATE ADHESIVE RESIN CEMENT
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): 3M DEUTSCHLAND; neuss ; GM
• Manufacturer Contact: carl-schurz-strabe 1; neuss 41453 ; 9815270013
• MDR Report Key: 4990601
• MDR Text Key: 23383815
• Report Number: 9611385-2015-00011
• 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: Followup,Followup
• Report Date: 07/10/2015

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: Not provided
• Initial Date FDA Received: 08/07/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/10/2015; 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR