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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC
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3M ESPE DENTAL PRODUCTS LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC Back to Search Results
Catalog Number 2914A2-LT-S
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Sensitivity of Teeth (2427)
Event Type  Injury  
Event Description
A dentist reported that 2-3 patients had need for endodontic treatment.These patients had dental restorations made from 3m espe lava ultimate cad/cam restorative for cerec.The reporting dentist indicated that of 30-40 patients who experienced debonding of the crown and sensitivity, the sensitivity was severe in about 8-10 patients.Of these patients with severe sensitivity, 2-3 required endodontic treatment.The sensitivity in the other patients resolved upon crown replacement.All patients are reported as currently fine.
 
Event Description
A dentist reported that 2-3 patients had need for endodontic treatment.These patients had dental restorations made from 3m espe lava ultimate cad/cam restorative for cerec.The reporting dentist indicated that of 30-40 patients who experienced debonding of the crown and sensitivity, the sensitivity was severe in about 8-10 patients.Of these patients with severe sensitivity, 2-3 required endodontic treatment.The sensitivity in the other patients resolved upon crown replacement.All patients are reported as currently fine.
 
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Brand Name
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC
Manufacturer (Section D)
3M ESPE DENTAL PRODUCTS
saint paul MN
Manufacturer Contact
2510 conway avenue
saint paul, MN 55144-1000
6517331179
MDR Report Key4990581
MDR Text Key23382017
Report Number3005174370-2015-00047
Device Sequence Number1
Product Code EBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110131
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Remedial Action Recall
Report Date 07/13/2015
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 Number2914A2-LT-S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/07/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Removal/Correction NumberRECALL # Z-2052-2015
Patient Sequence Number1
Patient Outcome(s) Other;
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