MAUDE Adverse Event Report: KERR CORPORATION NX3; DENTAL CEMENT

Catalog Number 33643

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Tooth Fracture (2428)

Event Type  Injury  

Event Description

During a follow up phone call with the doctor on (b)(6) 2014, it was alleged that twenty-six (26) patients had experienced the loss of a crown approximately three (3) weeks after placement with the nx3 dual cure clear product.This is the sixteenth of twenty-six (26) reports.

Manufacturer Narrative

Although the doctor identified two (2) different lot numbers associated with the debonding of crowns, he could not verify which lot was used on the patient; therefore, no lot numbers were identified in this report.The lot numbers involved in the alleged incident include 4844571 and 5007512.Specific patient information with regard to gender, age, and weight was not provided.The patient returned to the office and a new crown was cemented using a different product.To date, the patient is doing fine.The product from lot #4844571 was returned and a physical evaluation was performed, yielding results within specification.The product from lot #5007512 was not returned; therefore, a physical evaluation was performed on a retained sample, yielding results within specifications.In addition, no similar complaints were received with regard to both of the reported lots.

• Brand Name: NX3
• Type of Device: DENTAL CEMENT
• 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 west collins avenue; orange, CA 92867 ; 7145167634
• MDR Report Key: 3767012
• MDR Text Key: 4486094
• Report Number: 2024312-2014-00239
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013609
• 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: 02/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 33643
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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