MAUDE Adverse Event Report: KERR CORPORATION POINT 4 COMPOSITE; TOOTH SHADE RESIN MATERIAL

Catalog Number 29892

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The color of the returned product was evaluated.The product did not meet specifications; therefore, a retained sample was evaluated, yielding results within specifications.Since no similar complaints have been received with regard to this lot, and both the dhr and retained samples show this lot to be manufactured and testing within specifications, it has been concluded that the returned product from this lot was compromised in the field, most likely due to improper storage conditions.Per the instructions for use, this product must be kept at ambient temperature.

Event Description

A doctor alleged that a patient had experienced a repeated procedure due to the point 4 composite color shifting to fairly yellow.

• Brand Name: POINT 4 COMPOSITE
• Type of Device: TOOTH SHADE RESIN MATERIAL
• 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: mark dzendzel ; 1717 west collins avenue; orange, CA 92867 ; 7145167802
• MDR Report Key: 5154977
• MDR Text Key: 28443950
• Report Number: 2024312-2015-00083
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013510
• 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: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 29892
• Device Lot Number: 5149709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2015
• 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
• Patient Age: 46 YR
• Patient Weight: 52