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 Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2014

Event Type  Injury  

Manufacturer Narrative

Additional reports will be made for the other patients with lava ultimate crowns in this practice who required tooth extraction.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 3005174370-2015-00091 and 9611385-2015-00053, describe the first and third device, respectively.

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 tooth extraction.Follow-up information provided by the office on (b)(6) 2015, detailed the case of a (b)(6) male patient who received a lava ultimate crown on tooth #14 secured with 3m espe scotchbond universal adhesive and 3m espe relyx ultimate adhesive resin cement on (b)(6) 2012.The patient had previously undergone root canal treatment on the tooth and the lava ultimate crown fractured revealing what was described as recurrent decay; dates of prior root canal treatment and crown fracture were not provided to 3m.The tooth was extracted on (b)(6) 2014.

• 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: 5182156
• MDR Text Key: 29792089
• Report Number: 9611385-2015-00052
• 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: 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: 56890
• Was Device Available for Evaluation?: No
• 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: 45 YR