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 No Code Available (3191)

Event Date 02/12/2014

Event Type  Injury  

Manufacturer Narrative

3m espe received this report on august 24, 2015 and has attempted to obtain more patient-specific information.Since the dentist was not able to provide the additional information, patient-specific reporting is not possible.Since this event involved three medical devices, three manufacturer reports are being submitted.Manufacturer report numbers 3005174370-2015-00065 and 9611385-2015-00029, describe the first and third device, respectively.

Event Description

On (b)(6) 2015, a dentist reported that a couple of patients required a root canal treatment.These patients had crowns made from 3m espe lava ultimate cad/cam restorative, and secured with 3m espe relyx ultimate cement and 3m espe scotchbond universal adhesive.Confirmation of the dates of treatment, exact number of patients involved and current health status of the affected patients have not been made available to 3m espe despite follow-up attempts.

Manufacturer Narrative

This follow-up report is being made to reflect the patient-specific information now available from the dental office.

Event Description

On (b)(6) 2015, a representative from the dental office provided patient-specific information; initially, this office indicated "a couple" of patients required root canal treatment.In total, the office has now provided information on 15 root canals involving 14 patients.This original report is being updated to reflect the patient-specific information for the one patient who required two root canals.This patient, a (b)(6) female, received crowns made from 3m espe lava ultimate cad/cam restorative for cerec on teeth #3 and #31 on (b)(6) 2013.These crowns were secured with 3m espe relyx ultimate adhesive resin cement and 3m espe scotchbond universal adhesive.On (b)(6) 2013, the patient reported biting pain and throbbing.The dentist adjusted the bite twice and referred the patient for root canal treatment, which took place on (b)(6) 2014.The patient is currently reported as fine.

• 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: 5094999
• MDR Text Key: 26445182
• Report Number: 9611385-2015-00028
• 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: Followup
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• 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: 10/07/2015
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR