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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KERR CORPORATION SONICFILL COMPOSITE; TOOTH SHADE RESIN MATERIAL
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KERR CORPORATION SONICFILL COMPOSITE; TOOTH SHADE RESIN MATERIAL Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Event Description
A doctor alleged that approximately ten (10) patients had experienced the replacement of a sonicfill restoration due to microleakage.This is the sixth of ten (10) reports.
 
Manufacturer Narrative
Specific patient information with regard to gender, age and weight was not provided.The doctor removed the sonicfill restoration and repeated the procedure using a different product.To date, the patient is doing fine.The product involved in the alleged incident was not returned and no lot number was provided; therefore, no evaluation can be conducted.
 
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Brand Name
SONICFILL COMPOSITE
Type of Device
TOOTH SHADE RESIN MATERIAL
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 Key3960499
MDR Text Key4622461
Report Number2024312-2014-00523
Device Sequence Number1
Product Code EBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091023
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 07/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2014
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 Received07/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
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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