MAUDE Adverse Event Report: PENTRON CLINICAL BUILD-IT FR; CORE BUILD-UP MATERIAL

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

A doctor alleged that the build-it fr core build-ups for two (2) patients had debonded upon removal of the temporary restoration.This is the second of two (2) reports.

Manufacturer Narrative

Specific information with regard to the patient's age and weight was not provided by the doctor.The patient had experienced the debonding of a core build-up.The doctor rebuilt the core and then cemented the patient's crown.The doctor declined to provide any further information with regard to this incident; therefore, no further information was able to be obtained.An update will be provided if any new information becomes available.The product was not returned and no lot number or catalog number was provided; therefore, no evaluation can be conducted.

• Brand Name: BUILD-IT FR
• Type of Device: CORE BUILD-UP MATERIAL
• Manufacturer (Section D): PENTRON CLINICAL; 1717 west collins avenue; orange CA 92867
• Manufacturer (Section G): KERR CORPORATION; 1717 west collins avenue; orange CA 92867
• Manufacturer Contact: kerri casino ; 1717 w collins ave; orange, CA 92867 ; 7145167634
• MDR Report Key: 3790315
• MDR Text Key: 4446117
• Report Number: 2024312-2014-00291
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• PMA/PMN Number: K000211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2014
• 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 Number: 1
• Treatment: CLEARFIL SE BOND
• Patient Outcome(s): Other; Required Intervention