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 Type  Injury  

Manufacturer Narrative

Patient-specific information was not obtained despite multiple attempts at follow-up.As such, this report is being made to cover all three possibly impacted patients.Since this event involved three medical devices, three manufacturer reports are being submitted.This report describes the second device.Manufacturer report numbers 3005174370-2015-00130 and 9611385-2015-00111 describe the first and third device, respectively.

Event Description

On (b)(6) 2015, a dental professional informed 3m about three patients who required endodontic treatment.These patients had a 3m espe lava ultimate crowns secured with 3m espe relyx ultimate adhesive resin cement and 3m espe scotchbond universal adhesive.No details on dates of treatment, pre-existing tooth health or outcomes were made available to 3m despite multiple attempts at follow-up.As such, the role that the 3m products may or may not have played in the reported endodontic events is unclear.

• 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: 5316995
• MDR Text Key: 34071604
• Report Number: 9611385-2015-00110
• 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: 11/24/2015

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: Dentist
• Device Catalogue Number: 56890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention