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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 Device Contamination with Chemical or Other Material (2944)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Event Description
A doctor alleged that black specks were present in the sonicfill composite after light curing restorations for two (2) patients.This is the first of two (2) reports.
 
Manufacturer Narrative
Although the office identified two (2) different lots associated with the black specks, the office could not verify which lot had been used on the patient; therefore, no lot numbers were identified in this report.The lots involved in the alleged incident include lot numbers 4874471 and 4870448.The doctor drilled out the composite material and replaced the patient's restoration during the same office visit.To date, the patient is doing fine.The products involved in the alleged incident were returned and a visual evaluation was performed on both lots, yielding results within specifications.In addition, dhr reviews indicated that there were no deviations from the manufacturing process.
 
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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 Key3565917
MDR Text Key21881439
Report Number2024312-2014-00008
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 12/11/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dentist
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/11/2013
Initial Date FDA Received01/09/2014
Was Device Evaluated by Manufacturer? Yes
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;
Patient Age20
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