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

Catalog Number 56874

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 01/14/2014

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.Section of this report describes the second device.Section of manufacturer report number 3005174370-2015-00092 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 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 cad/cam restorative for cerec crown on tooth #31 secured with 3m espe relyx unicem 2 cement on (b)(6) 2012.The crown debonded, which led to sensitivity; further details on when the debonding occurred and the duration of the sensitivity were not provided.On (b)(6) 2014, a root canal was performed.The patient is currently reported to be asymptomatic.

• 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: 5193113
• MDR Text Key: 30010088
• Report Number: 9611385-2015-00054
• 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

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 56874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2015
• 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: 42 YR