MAUDE Adverse Event Report: KERR CORPORATION TEMPSPAN TRANSPARENT CEMENT; CROWN AND BRIDGE, TEMPORARY, RESIN

Catalog Number N69CB

Device Problem Device Operates Differently Than Expected (2913)

Event Type  Injury  

Event Description

A doctor's office alleged that six (6) patients had experienced a darkening of their teeth upon the removal of temporary restorations which had been placed using the tempspan transparent product.This is the fourth of six (6) reports.

Manufacturer Narrative

Patient specifics with regard to age, gender, and weight were not provided.The doctor cleaned the patient's tooth with pumice before cementing the permanent restoration.To date, the patient is doing fine.The product was not returned; therefore, a retained sample from the same lot was evaluated, yielding results within specifications.In addition, no similar complaints were received with regard to this lot.

• Brand Name: TEMPSPAN TRANSPARENT CEMENT
• Type of Device: CROWN AND BRIDGE, TEMPORARY, RESIN
• 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: 3608687
• MDR Text Key: 4157033
• Report Number: 2024312-2014-00084
• Device Sequence Number: 1
• Product Code: EBG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053565
• 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: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 08/01/2014
• Device Catalogue Number: N69CB
• Device Lot Number: 4635138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2012
• 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