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 10/27/2015

Event Type  Injury  

Manufacturer Narrative

Since this event involved three medical devices, three manufacturer reports are being submitted.This report describes the second device.Manufacturer report numbers 3005174370-2015-00125 and 9611385-2015-00106, describe the first and third device, respectively.

Event Description

On (b)(6) 2015, a dental professional informed 3m about a patient who required tooth extraction.This patient had a 3m espe lava ultimate cad/cam restorative for cerec crown secured with 3m espe relyx ultimate adhesive resin cement and 3m espe scotchbond universal adhesive the patient, a (b)(6) female patient, received the lava ultimate crown on tooth #19 on (b)(6) 2014.It was noted that this patient had a pre-existing root canal on this tooth (performed on (b)(6) 2005).In (b)(6) 2015, the patient was examined and no evidence of a problem was noted upon examination or review of bitewing x-rays.On (b)(6) 2015, films (periapical and images) showed a great deal of decay.The crown was removed and the dentist attempted to remove the decay.No tooth structure above the gum line was left; only the post remained.The patient is scheduled on (b)(6) 2015, for tooth extraction, bone grafting and a possible implant.

• 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: 5280640
• MDR Text Key: 33097872
• Report Number: 9611385-2015-00105
• 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: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• 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: 11/10/2015
• 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: 66 YR