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 09/22/2015

Event Type  Injury  

Manufacturer Narrative

Since this event involved three medical devices, three manufacturer reports are being submitted.Section of this report describes the second device.Section of manufacturer report numbers 3005174370-2015-00124 and 9611385-2015-00104, 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) male patient, received the lava ultimate crown on tooth #5 on (b)(6) 2014.Bitewing x-rays taken in (b)(6) of 2015 showed no evidence of problem.On (b)(6) 2015, the patient's crown debonded and the crown was re-cemented by another dentist who noted decay.The patient was referred to a periodontist who was unable to salvage the remaining tooth structure and who recommended extraction; extraction was performed on (b)(6) 2015, and the patient is currently reported to be healing.

• 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: 5279643
• MDR Text Key: 33098779
• Report Number: 9611385-2015-00103
• 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: 58 YR