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

Catalog Number 56890

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Missing Value Reason (3192)

Event Type  Injury  

Manufacturer Narrative

3m espe received this report on (b)(4) 2015 and has attempted to obtain more patient-specific information.Since the dentist was not willing to provide patient-specific information, patient-specific reporting is not possible.Since this event involved three medical devices, three manufacturer reports are being submitted.This report describes the second device.Manufacturer report numbers 3005174370-2015-00063 and 9611385-2015-00025, describe the first and third device, respectfully.

Event Description

On (b)(6) 2015, a dentist reported that approximately 25% of 200 patients had need for endodontic treatment.These patients had crowns made from 3m espe lava ultimate cad/cam restorative for cerec, which were seated with 3m espe 3m espe relyx ultimate cement and 3m espe scotchbond universal adhesive.The reporting dentist declined to provide additional patient-specific information and the dates on which the crowns were placed and endodontic treatment occurred; as such, these events are being collectively reported.The dentist did state that the patients still remaining in her practice, all are fine after the endodontic treatment.

• Brand Name: RELYX ULTIMATE ADHESIVE RESIN CEMENT
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; carl-schurz-strabe 1; neuss, 41453 ; GM 41453
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH-SEEFELD; espe platz, d82229; seefeld, D8222 9; GM D82229
• Manufacturer Contact: thomas meindl ; carl-schurz-strabe 1; neuss, 41453 ; GM 41453
• MDR Report Key: 5079565
• MDR Text Key: 25875676
• Report Number: 9611385-2015-00024
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110508
• 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: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 56890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other