MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 3114A2-HT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient-specific information was not obtained despite multiple attempts at follow-up.As such, this report is being made to cover all three possibly impacted patients.Since this event involved three medical devices, three manufacturer reports are being submitted.A section of this report describes the first device.Section of manufacturer report numbers 9611385-2015-00110 and 9611385-2015-00111 describe the second and third device, respectively.

Event Description

On (b)(6) 2015, a dental professional informed 3m about three patients who required endodontic treatment.These patients had a 3m espe lava ultimate cad/cam restorative for e4d crowns secured with 3m espe relyx ultimate adhesive resin cement and 3m espe scotchbond universal adhesive.No details on dates of treatment, pre-existing tooth health or outcomes were made available to 3m despite multiple attempts at follow-up.As such, the role that the 3m products may or may not have played in the reported endodontic events is unclear.

• Brand Name: LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D
• 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: 5317252
• MDR Text Key: 34071550
• Report Number: 3005174370-2015-00130
• 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: Dentist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 3114A2-HT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2015
• 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