MAUDE Adverse Event Report: KERR CORPORATION BUILD IT FR; TOOTH SHADE RESIN MATERIAL

Catalog Number N32FE

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A doctor alleged that multiple patients had experienced the debonding of posts after placement with build it fr material and bond 1 products.

Manufacturer Narrative

Specific patients' information with regard to age, gender, and weight was not provided.The doctor could not recall specific patient or incident details.It was reported that the doctor had to re-do the cores and seated the crowns for each of the patients, without further incident.To date, the patients are doing fine.The product was not returned and no lot number was provided; therefore, no evaluations can be conducted.

• Brand Name: BUILD IT FR
• 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: kerri casino ; 1717 west collins avenue; orange, CA 92867 ; 7145167634
• MDR Report Key: 3836622
• MDR Text Key: 21317861
• Report Number: 2024312-2014-00296
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994359
• 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: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: N32FE
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2014
• 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
• Treatment: BOND1 DUAL CURE; BUILD-IT
• Patient Outcome(s): Other; Required Intervention