MAUDE Adverse Event Report: PENTRON CLINICAL FLOW-IT ALC; TOOTH SHADE RESIN MATERIAL

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

A doctor alleged that a patient had experienced the debonding of a veneer from tooth #24 on two (2) separate occasions.

Manufacturer Narrative

Specific patient information with regard to age and weight was not provided by the doctor.The doctor was not definitive as to whether flow-it alc had been used to initially cement the veneer; however, after it had debonded the first time, he used flow-it alc and a competitors bonding agent to re-cement the restoration.The veneer debonded a second time; therefore, the doctor took a new impression and a new veneer was made.The new veneer was cemented using a new syringe of flow-it alc, without further incident.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.

• Brand Name: FLOW-IT ALC
• Type of Device: TOOTH SHADE RESIN MATERIAL
• Manufacturer (Section D): PENTRON CLINICAL; 1717 west collins avenue; orange CA 92867
• Manufacturer (Section G): PENTRON; 1717 west collins avenue; orange CA 92867
• Manufacturer Contact: kerri casino ; 1717 w collins ave; orange, CA 92867 ; 7145167634
• MDR Report Key: 4013030
• MDR Text Key: 4690558
• Report Number: 2024312-2014-00581
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952662
• 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: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2014
• 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 Received: 07/17/2014
• 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: KURARAY DENTAL CLEARFIL SE
• Patient Outcome(s): Other; Required Intervention