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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KERR CORPORATION NX3; DENTAL CEMENT

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KERR CORPORATION NX3; DENTAL CEMENT Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Event Description
A doctor alleged that multiple patients had experienced the loss of a crown after placement with the nx3 product.
 
Manufacturer Narrative
Specific information with regard to patient genders, ages, and weights was not provided.The doctor cleaned out the crowns and re-cemented them using a different product for each of the patients.To date, each of the patients are doing fine.The product was not returned and no lot number or catalog number was provided; therefore, no evaluation can be conducted.
 
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Brand Name
NX3
Type of Device
DENTAL CEMENT
Manufacturer (Section D)
KERR CORPORATION
1717 west collins avenue
orange CA 92867
Manufacturer (Section G)
KERR CORPORATION
1717 west collins avenue
orange CA 92867
Manufacturer Contact
kerri casino
1717 west collins avenue
orange, CA 92867
7145167634
MDR Report Key3767667
MDR Text Key4379086
Report Number2024312-2014-00285
Device Sequence Number1
Product Code EMA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062519
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 04/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dentist
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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