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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY CAULK CALIBRA CERAM; CEMENT, DENTAL
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DENTSPLY CAULK CALIBRA CERAM; CEMENT, DENTAL Back to Search Results
Catalog Number 607194K
Device Problems Increased Sensitivity (2535); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Sensitivity of Teeth (2427)
Event Type  Injury  
Manufacturer Narrative
Therefore, because this event resulted in a serious injury, it is reportable per 21 cfr part 803.This report is for the fourth patient.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
 
Event Description
It was reported that several patients experienced post operative pain and sensitivity after cementation with prime & bond active and calibra ceram cement.The dentist claims that endodontic therapy had to be performed on several teeth.The crowns were recemented with another cement and bonding agent.
 
Manufacturer Narrative
Evaluation of retained product failed on the low end of the spec, meaning the product was too translucent and presents no health hazard.
 
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Brand Name
CALIBRA CERAM
Type of Device
CEMENT, DENTAL
Manufacturer (Section D)
DENTSPLY CAULK
38 w. clark ave.
milford DE 19963
MDR Report Key8661210
MDR Text Key146779559
Report Number2515379-2019-00012
Device Sequence Number1
Product Code EMA
Combination Product (y/n)N
PMA/PMN Number
K073173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 08/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number607194K
Device Lot Number180620
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/02/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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