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

Catalog Number 41258

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Sensitivity of Teeth (2427)

Event Date 07/01/2014

Event Type  Injury  

Event Description

On (b)(6), 2014, a dealer representative informed 3m espe that a dental professional who used 3m espe lava ultimate cad/cam restorative for e4d, 3m espe scotchbond universal adhesive and 3m espe relyx ultimate cement had a male patient who ultimately required endodontic treatment.Upon follow-up directly with the dental professional, it was learned that the patient experienced recurrent sensitivity which resulted in the need for two root canals.

Manufacturer Narrative

There were three suspect devices involved in this event.This report describes the second suspect device.Manufacturer report numbers 3005174370-2015-00004,00006 provide information on the first and third suspect devices involved in this event, respectively.

• Brand Name: 3M ESPE SCOTCHBOND UNIVERSAL
• 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: 41453 neuss germany; neuss ; 9815270013
• MDR Report Key: 4459615
• MDR Text Key: 5395895
• Report Number: 3005174370-2015-00005
• 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,Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/30/2014

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: 12/30/2014
• Initial Date FDA Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR