MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH RELYX UNICEM 2 CEMENT; DENTAL CEMENT

Catalog Number 56848

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Since this event involved four medical devices, four manufacturer reports are being submitted.This report describes the second device.Manufacturer report numbers 3005174370-2015-00126, 9611385-2015-00108, and 9611385-2015-00109, describe the first, third and fourth device, respectively.

Event Description

On (b)(6) 2015, a dental assistant reported one patient who required a tooth extraction.The patient had a restoration made from 3m espe lava ultimate cad/cam restorative for cerec which was secured with 3m espe relyx ultimate adhesive resin cement, relyx univcem 2 cement and scotchbond universal adhesive.On (b)(6) 2015, it was reported that the doctor was not 100% sure that the extraction was due to the crown because there were other factors involved.

• Brand Name: RELYX UNICEM 2 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: 5287967
• MDR Text Key: 33272394
• Report Number: 9611385-2015-00107
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 56848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention