MAUDE Adverse Event Report: 3M DEUTCHSLAND 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 Type  No Answer Provided  

Event Description

On (b)(6) 2014, 3m espe was contacted by a dentist who reported that after use of 3m espe scotchbond universal adhesive and 3m espe relyx ultimate cement to secure crowns (non-3m products), approximately 15% of the treated patients required endodontic treatment; he subsequently revised the number to 5% of the patients, but was unable to provide 3m espe with an estimate of the total number impacted.The dentist did note that all of the impacted patients had badly broken down teeth and that the potential for the need for endodontic treatment was present.All patients received a remade crown and are all reported as currently fine.Since there were two suspect medical devices involved in this event, two manufacturer reports are being submitted.

Manufacturer Narrative

Upon review of the dental professional's technique, it appears that perhaps the tooth preparations may have been over-dried.Such a situation could lead to the sensitivity that was noted prior to the endodontic treatment.Additionally the dentist stated that he obtained the same sensitivity results when he used a competitor's product ((b)(4)), which indicates that there's a general handling problem.The first suspect device is described in this report, the second suspect device is described within manufacturer report number 9611385-2014-00004.

• Brand Name: 3M ESPE SCOTCHBOND UNIVERSAL
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): 3M DEUTCHSLAND GMBH; neuss ; GM
• Manufacturer Contact: carl-schurz-strasse 1; neuss 41453 ; 9815270013
• MDR Report Key: 3941803
• MDR Text Key: 20265396
• Report Number: 9611385-2014-00003
• 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: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial

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: 05/29/2014
• Initial Date FDA Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other