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

Catalog Number N33A

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A doctor alleged that two (2) patients had experienced the debonding of restorations after placement with cement it.This is the first of two (2) reports.

Manufacturer Narrative

Specific patient with regard to age and weight was not provided.The doctor re-cemented the bridge for the patient using a different product, without further incident.To date, the patient is doing fine.The products involved in the alleged incidents were returned and a 'gel time' and 'set time' were performed, yielding results within specifications.A dhr review revealed that there were no deviations from the manufacturing process.In addition, no similar complaints were 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: 3866490
• MDR Text Key: 4461732
• Report Number: 2024312-2014-00438
• 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: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 02/01/2014
• Device Catalogue Number: N33A
• Device Lot Number: 4-880086
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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