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

Catalog Number 35640

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

A doctor's office alleged that two (2) patients had experienced the loss of a crown after placement with the nexus rmgi product.This is the first of two (2) reports.

Manufacturer Narrative

Patient specific with regard to age and weights were not provided by the doctor.The doctor cleaned the crown for tooth #18 and re-cemented the crown for the patient during the same visit, without further incident.To date, the patient is doing fine.The returned product was received in a condition which made analysis impossible; therefore, a 'gel time' and 'set time' tests of the retain sample was evaluated, 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 regards 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: 3973872
• MDR Text Key: 4632938
• Report Number: 2024312-2014-00500
• 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: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 10/01/2014
• Device Catalogue Number: 35640
• Device Lot Number: 4842958
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2013
• 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