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  

Event Description

On (b)(6) 2015, a dental professional reported to 3m espe that some of his patients required endodontic treatment to relieve persistent sensitivity experienced after placement of 3m espe lava ultimate cad/cam restorative for e4d.The dentist was unable to provide any further detail on the number of patients involved or the dates on which these endodontic treatments were performed.Companion products used to secure the crowns were 3m espe relyx ultimate cement and 3m espe scotchbond universal adhesive, as well as other non-3m espe cements.Since this event involved three medical devices, three mfr reports are being submitted.

Manufacturer Narrative

3m espe rec'd this report on (b)(6) 2015, and has attempted to obtain more specific information.However, because the reported events happened sometime between 2011 and 2015 and because the dentist was not willing or able to provide additional information, patient-specific reporting is not possible.This report describes the third device.Mfr report numbers 3005174370-2015-00042 and 3005174370-2015-00043 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 (Section G): ESPE PLATZ; d82229; seefeld ; GM
• Manufacturer Contact: carl-schurz-strabe 1; neuss 41453 ; 9815270013
• MDR Report Key: 4945032
• MDR Text Key: 20153290
• Report Number: 3005174370-2015-00044
• 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
• Type of Report: Initial
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• 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: 06/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other