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

Catalog Number 56874

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 08/12/2013

Event Type  Injury  

Manufacturer Narrative

Additional reports will be made for the other patients with lava ultimate crowns in this practice who required root canal treatment.Since this event involved two medical devices, two manufacturer reports are being submitted.This report describes the second device.Manufacturer report number 3005174370-2015-00090 describes the first device.

Event Description

On (b)(6) 2015, a representative from a dental office reported that patients with 3m espe lava ultimate cad/cam restorative for cerec crowns required root canal treatment.Follow-up information provided by the office on (b)(6) 2015, detailed the case of a (b)(6) female patient who received a lava ultimate crown on tooth #20 secured with 3m espe relyx unicem 2 cement on (b)(6) 2012.The patient experienced pain upon biting (onset date of symptoms was not provided) and on (b)(6) 2013, a root canal was performed.The patient is currently reported to be asymptomatic.

• Brand Name: RELYX UNICEM 2 CLICKER REFILL
• 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: 5182154
• MDR Text Key: 29403020
• Report Number: 9611385-2015-00051
• 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: 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: 56874
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2015
• Initial Date FDA Received: 10/27/2015
• 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: 57 YR