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

Catalog Number 56846

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Since this event involved three medical devices, three mdrs are being submitted.This mdr report is for the third medical device.Mdrs 300517430-2016-00048 and 3005174370-2016-00049 are for the first and second medical device, respectively.Device was not sent to us.

Event Description

On (b)(6) 2016, a dental professional reported that patients with a 3m espe lava ultimate cad/cam restorative for cerec crowns (2914a2-lt and 2914a3-lt) secured with relyx unicem 2 automix required tooth extraction.Additional information regarding the number of patients impacted and details on the cases have been requested; to date, no further information is available.

• Brand Name: 3M ESPE RELYX UNICEM 2 AUTOMIX
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; carl-schurz-strabe 1; neuss, 41453 ; GM 41453
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH-SEEFELD; espe platz; seefeld, 82229 ; GM 82229
• Manufacturer Contact: thomas meindl ; carl-schurz-strabe 1; neuss, 41453 ; GM 41453
• MDR Report Key: 5633050
• MDR Text Key: 44448199
• Report Number: 9611385-2016-00005
• 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: Dentist
• Type of Report: Initial
• Report Date: 04/05/2016

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: 56846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2016
• Initial Date FDA Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention