MAUDE Adverse Event Report: KERR CORPORATION NEXUS RMGI; CEMENT, DENTAL

Catalog Number 35642

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

A doctor's office alleged that a patient had experienced the loss of a crown after placement with the nexus rmgi product.

Manufacturer Narrative

Specific information with regard to the patient age and weight was not provided by the doctor.The doctor re-cemented the crown for the patient using a different product, without further incident.To date, the patient is doing fine.The product alleged in this incident was not returned; therefore, an adhesive strength test of a retain sample was 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: NEXUS RMGI
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): KERR CORPORATION; 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: 4041630
• MDR Text Key: 4865016
• Report Number: 2024312-2014-00572
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123595
• 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: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 11/01/2014
• Device Catalogue Number: 35642
• Device Lot Number: 4875328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2014
• Initial Date FDA Received: 08/27/2014
• 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
• Patient Outcome(s): Other; Required Intervention