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

Dentist reported that following the use of 3m espe lava ultimate cad/cam restorative for cerec, 3m espe relyx ultimate adhesive resin cement and 3m espe schtchbond universal adhesive to prepare and seat full coverage crowns, 5-6 patients required endodontic treatment due to persistent sensitivity.Following the root canal in all of these cases, the patients are reported as fine; non-3m espe products were used in the replacement procedure.No further details on the patients or teeth involved were made available to 3m espe.

Manufacturer Narrative

There were three devices involved in this event.This report describes the third device.Manufacturer report numbers 3005174370-2015-00021 and 3005174370-2015-00022 provide information on the first and second device involved in this event, 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; seefeld D822 29; GM D82229
• Manufacturer Contact: carl-schurz-strasse 1; neuss 41453 ; 815270013
• MDR Report Key: 4660185
• MDR Text Key: 5680992
• Report Number: 3005174370-2015-00023
• 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: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/05/2015
• Initial Date FDA Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Other