MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 2914A2-LT-S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Since this event involved four medical devices, four manufacturer reports are being submitted.Manufacturer report numbers 9611385-2015-00107, 9611385-2015-00108, and 9611385-2015-00109 describe the second, third device and fourth device, respectively.

Event Description

On (b)(6) 2015, a dental assistant reported one patient who required a tooth extraction.The patient had a restoration made from 3m espe lava ultimate cad/cam restorative for cerec which was secured with 3m espe relyx ultimate adhesive resin cement, relyx univcem 2 cement and scotchbond universal adhesive.On (b)(6) 2015, it was reported that the doctor was not 100% sure that the extraction was due to the crown because there were other factors involved.

• Brand Name: LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; 2510 conway avenue; st. paul MN 55144 1000
• Manufacturer (Section G): 3M ESPE DENTAL PRODUCTS-IRVINE; 2111 mcgaw avenue; irvine CA 92614
• Manufacturer Contact: angie draper ; 2510 conway avenue; st. paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 5288056
• MDR Text Key: 33255303
• Report Number: 3005174370-2015-00126
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110131
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dental Assistant
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 2914A2-LT-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: Z-2052-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention