MAUDE Adverse Event Report: KERR CORPORATION TEMPBOND; CEMENT, DENTAL

Catalog Number 33215

Device Problem Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A doctor alleged that he had difficulties removing permanent restorations for teeth #29 and #30 after placement with tempbond temporary cement for a patient.

Manufacturer Narrative

To date, the patient is doing fine.The doctor removed tooth #29; however, the doctor had to cut off the crown for tooth #30.A new crown was re-made and will be placed for the patient.The product alleged in this incident was not returned; therefore, a 'visual' and 'physical' test of the retain sample was performed, yielding results within specification.

• Brand Name: TEMPBOND
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): KERR CORPORATION; 28200 wick road; romulus MI 48174
• Manufacturer (Section G): KERR CORPORATION; 28200 wick road; romulus MI 48174
• Manufacturer Contact: kerri casino ; 1717 w collins ave; orange, CA 92867 ; 7145167634
• MDR Report Key: 3720460
• MDR Text Key: 4337935
• Report Number: 1815757-2014-00001
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003658
• 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: 03/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 33215
• Device Lot Number: 3-1130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2014
• Initial Date FDA Received: 04/02/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR