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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH RELYX ULTIMATE ADHESIVE RESIN CEMENT; DENTAL CEMENT
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3M DEUTSCHLAND GMBH RELYX ULTIMATE ADHESIVE RESIN CEMENT; DENTAL CEMENT Back to Search Results
Catalog Number 56890
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Increased Sensitivity (2065)
Event Type  Injury  
Event Description
On (b)(6) 2013, a dentist reported that some of his pts had need for endodontic treatment.These pts had dental restorations made from 3m espe lava ultimate cad/cam restorative for e4d, which were seated with 3m espe relx ultimate cement and 3m espe scotchbond universal adhesive.The reporting dentist indicated that approx 240 of his pts experienced sensitivity.The dentist was unable to provide a number for those requiring endodontic treatment because the events occurred over a period of several years (2011 to 2015).
 
Event Description
On (b)(6) 2013, a dentist reported that some of his pts had need for endodontic treatment.These pts had dental restorations made from 3m espe lava ultimate cad/cam restorative for e4d, which were seated with 3m espe relx ultimate cement and 3m espe scotchbond universal adhesive.The reporting dentist indicated that approx 240 of his pts experienced sensitivity.The dentist was unable to provide a number for those requiring endodontic treatment because the events occurred over a period of several years (2011 to 2015).Since this event involved three medical devices, three mfr reports are being submitted.This report describes the first device.Mfr report numbers (b)(4) and (b)(4), describe the second and third device, respectfully.
 
Manufacturer Narrative
The 3m espe received this report on june 24, 2015, and has attempted to obtain more specific info.However, because the reported events happened sometime between 2011 and 2015 and because the dentist was not willing or able to provide add'l info, pt-specific reporting is not possible.
 
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Brand Name
RELYX ULTIMATE ADHESIVE RESIN CEMENT
Type of Device
DENTAL CEMENT
Manufacturer (Section D)
3M DEUTSCHLAND GMBH
neuss
GM 
Manufacturer Contact
carl-schurz-strasse 1
neuss 41453
9815270013
MDR Report Key4995015
MDR Text Key22830568
Report Number9611385-2015-00006
Device Sequence Number1
Product Code EMA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110508
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Report Date 07/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Catalogue Number56890
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/06/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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