MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS 3M ESPE FILTEK SUPREME ULTRA UNIVERSAL; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 4911A2B

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 07/10/2017

Event Type  Injury  

Manufacturer Narrative

A follow-up interview by 3m showed a high probability that disregard of the instructions for use may have led to these adverse events.It appears that there's is a certain possibility for leakages and air inclusions, which subsequently may have resulted in the pulpitic sensitivities.

Event Description

On (b)(6) 2017, it was reported to 3m that a (b)(6) year-old male patient required a root canal following unresolved sensitivity after a restorative treatment with 3m espe filtek supreme xte universal restorative (also known as filtek supreme ultra universal restorative).On (b)(6) 2017, the restorative was removed and replaced with a cement containing eugenol; the symptoms persisted and a root canal treatment was performed on (b)(6) 2017.The root canal treatment was performed without any complications and the patient fully recovered.Upon follow-up, the dentist revealed that there were two other root canal treatments involving 3m espe filtek supreme xte universal restorative in the past, but did not add any further information.

• Brand Name: 3M ESPE FILTEK SUPREME ULTRA UNIVERSAL
• 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; 2510 conway avenue; st. paul MN 55144 1000
• Manufacturer Contact: angie draper ; 2510 conway avenue; st. paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 6778549
• MDR Text Key: 82400041
• Report Number: 3005174370-2017-00043
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 4911A2B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR