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 09/16/2014

Event Type  Injury  

Manufacturer Narrative

The other 13 patient-specific events provided by this office are being reported separately.Since this event involved three medical devices, three manufacturer reports are being submitted.Section of manufacturer report numbers 3005174370-2015-00102 and 9611385-2015-00074, 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) male patient who received a crown made from 3m espe lava ultimate cad/cam restorative for cerec on tooth #15 on (b)(6) 2014.This crown was secured with 3m espe relyx ultimate adhesive resin cement and 3m espe scotchbond universal adhesive.On (b)(6) 2014, the patient reported temperature sensitivity and pain; he was referred for endodontic treatment at that time.The endodontic procedure was performed on (b)(6) 2014.The patient's status is currently 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: 5206264
• MDR Text Key: 30568476
• Report Number: 9611385-2015-00073
• 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

• 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: 10/07/2015
• Initial Date FDA Received: 11/05/2015
• 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: 42 YR