MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH 3M ESPE RELYX ULTIMATE; CEMENT, DENTAL

Catalog Number 56890

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Sensitivity of Teeth (2427)

Event Type  No Answer Provided  

Event Description

On (b)(6) 2014, 3m espe was contacted by a dentist who reported that following placement of 3m espe lava ultimate crows, three patients required endodontic treatment to address sensitivity: also used on the crown placement procedure were 3m espe scotchbond universal adhesive and 3m espe relyx ultimate cement.The adhesive was not light cured prior to placement of the crown/cement in these patients.Following endodontic treatment, the crows were replaced with alternate products and the pts are reported as fine.

Manufacturer Narrative

There were three suspect devices involved in this event.This report descries the first suspect device.Manufacturer reports numbers 3005174370-2013-00013 and 3005174370-2013-00014 provide info on the second and third suspect devices involved in this event, respectfully.

• Brand Name: 3M ESPE RELYX ULTIMATE
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; neuss ; GM
• Manufacturer (Section G): ESPE PLATZ; seefeld D822 29; GM D82229
• Manufacturer Contact: carl-schurz-strasse 1; neuss D8222-9 ; 9815270013
• MDR Report Key: 3841324
• MDR Text Key: 4681761
• Report Number: 3005174370-2014-00015
• 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: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 56890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention