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

Catalog Number N33AC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A doctor's office alleged that the cement-it had set up too quickly during a patient's procedure.

Manufacturer Narrative

The doctor reported that the product had set up too quickly while seating six (6) crowns for the patient and the crowns for tooth #7 and #9 could not be fully seated.The doctor adjusted the occlusal surfaces and the patient left the office.The patient had returned on (b)(6) 2014 for removal of the crowns for tooth #7 and #9.A new impression was made and the patient is scheduled to return on (b)(6) 2014 for cementation of the new crowns.To date, the patient is doing fine.Kerr corporation has requested that the office report any new information with regard to this patient.An update will be provided if any new information becomes available.The product involved in the alleged incident was returned in a condition which made analysis impossible; therefore, a physical evaluation was performed on a retained sample, yielding results within specifications.In addition, no similar complaints have been received with regard to this lot.

• 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: 3929436
• MDR Text Key: 4601642
• Report Number: 2024312-2014-00492
• 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: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 03/01/2015
• Device Catalogue Number: N33AC
• Device Lot Number: 4895806
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: No
• 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