MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS RELYX ULTIMATE CEMENT; DENTAL CEMENT

Catalog Number 56890

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Erosion (1750); Tissue Damage (2104); Tissue Breakdown (2681)

Event Date 02/16/2015

Event Type  Injury  

Event Description

On june 17, 2015, 3m espe was made aware of a case in which a pt with a 3m espe lava ultimate cad/cam restorative for cerec which was secured with 3m espe relyx ultimate cement and 3m espe scotchbond universal adhesive was recommended to have the tooth extracted, a bone graft performed and an implant placed.This pt had the crown placed on tooth #30 on (b)(6) 2013.On (b)(6) 2014, the crown debonded and was replaced (with the same three 3m espe products).On (b)(6) 2015, the pt reported to the dentist that the tooth did not feel right and that the crown was loose upon removal of the crown, the dentist noted a foul odor.An x-ray taken on the same day showed a breakdown of the tooth structure between the roots.The tooth was temporized and the pt referred to an oral surgeon for the extraction.At the time of this report, 3m espe does not know if the extraction has occurred.Since this event involved three medical devices, three mfr reports are being submitted.

Manufacturer Narrative

Mfr report numbers 3005174370-2015-00039 and 3005174370-2015-00041, describe the first and third device, respectfully.

• Brand Name: RELYX ULTIMATE CEMENT
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; saint paul MN
• Manufacturer Contact: carl-schurz-strasses 1; neuss ; 9815270013
• MDR Report Key: 4917854
• MDR Text Key: 6050067
• Report Number: 3005174370-2015-00040
• 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: 06/17/2015

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: Health Professional
• Device Catalogue Number: 56890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR