MAUDE Adverse Event Report: PENTRON CLINICAL CEMENT-IT; DENTAL CEMENT

Device Problems Failure To Adhere Or Bond (1031); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A doctor's office alleged that a patient had experienced the debonding of restoration after placement with cement it.

Manufacturer Narrative

Specific patient information with regard to age and weight was not provided.It was reported the patient had her bridge re-cemented using a different product, without further incident.To date, the patient is doing fine.The product alleged in this incident was not returned and no lot number was provided; therefore, no evaluations can be conducted.

• Brand Name: CEMENT-IT
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): PENTRON CLINICAL; 1717 w collins ave; orange CA 92867
• Manufacturer (Section G): PENTRON CLINICAL; 1717 w collins avenue; orange CA 92867
• Manufacturer Contact: kerri casino ; 1717 w collins avenue; orange, CA 92867 ; 7145167634
• MDR Report Key: 4034987
• MDR Text Key: 21489032
• Report Number: 2024312-2014-00592
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000173
• 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: 08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2014
• 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: 08/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention