MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH 3M ESPE RELYX ULTIMATE; DENTAL CEMENT

Lot Number 631761

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

This event involved two medical devices, therefore two manufacturer reports are being submitted.This report describes the second device.Manufacturer report number 9611385-2016-00014 describes the first device.

Event Description

On november 25, 2016 it was reported to 3m (b)(4) that after a dental treatment on (b)(6) 2016 with our products 3m espe scotchbond universal and 3m espe relyx ultimate a patient started to suffer from pulpitic pain.Subsequently a root channel treatment was performed on (b)(6) 2016.Currently the patient is doing fine.A follow-up interview with the dentist showed, that the crown was attached before with a harvard cement from a competitor, but had to be removed because of decementation.The crown was then attached with 3m espe scotchbond universal and 3m espe relyx ultimate.The reason for the adverse event is highly probably a pulpitic infection caused by leakage after the debonding of the crown.

• Brand Name: 3M ESPE RELYX ULTIMATE
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; carl-schurz-strasse 1; neuss, 41453 ; GM 41453
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH-SEEFELD; espe platz; seefeld, 82229 ; GM 82229
• Manufacturer Contact: thomas meindl ; carl-schurz-strasse 1; neuss, 41453 ; GM 41453
• MDR Report Key: 6196864
• MDR Text Key: 63056772
• Report Number: 9611385-2016-00015
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110508
• 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
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 11/01/2017
• Device Lot Number: 631761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2016
• 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): Required Intervention
• Patient Age: 37 YR