MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH SCOTCHBOND UNIVERSAL ADHESIVE; AGENT, TOOTH BONDING, RESIN

Catalog Number 41258

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Sensitivity of Teeth (2427)

Event Type  Injury  

Manufacturer Narrative

The 3m espe received this report on june 24, 2015, and has attempted to obtain more specific info.However, because the reported events happened sometime between 2011 and 2015 and because the dentist was not willing or able to provide add'l info, pt-specific reporting is not possible.

Event Description

On (b)(6) 2013, a dentist reported that some of his pts had need for endodontic treatment.These pts had dental restorations made from 3m espe lava ultimate cad/cam restorative for e4d, which were seated with 3m espe relx ultimate cement and 3m espe scotchbond universal adhesive.The reporting dentist indicated that approx 240 of his pts experienced sensitivity.The dentist was unable to provide a number for those requiring endodontic treatment because the events occurred over a period of several years (2011 to 2015).Since this event involved three medical devices, three mfr reports are being submitted.This report describes the first device.Mfr report numbers 3005174370-2015-00046 and 9611385-2015-00006, describe the first and second device, respectfully.

• Brand Name: SCOTCHBOND UNIVERSAL ADHESIVE
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; neuss ; GM
• Manufacturer Contact: carl-schurz-strasse 1; neuss 41453 ; 9815270013
• MDR Report Key: 4995013
• MDR Text Key: 22835953
• Report Number: 9611385-2015-00007
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 41258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other