MAUDE Adverse Event Report: HERAEUS KULZER GMBH TRANSLUX® POWER BLUE; ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Catalog Number 66017507

Device Problem Output Problem (3005)

Patient Problem Difficulty Chewing (2670)

Event Type  malfunction  

Event Description

This is the third of six reports involving 6 different devices and 4 patients.A dental office has a curing light that they said is not curing properly.They have had to remove and re do 6 fillings so far.On (b)(6) 2013 spoke with assistant.She said that they only had 4 patients involved.She said that they would try the lights and when they did not cure they would grab another light and try it.They did not reuse it once it failed to cure.She said that they tried to cure for 40 seconds but the composite was still soft.She said that the lights did not seem to have enough curing power to cure the composite.

Manufacturer Narrative

(b)(4).Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution.Device has not been received for testing.Evaluation pending return of complaint unit.

• Brand Name: TRANSLUX® POWER BLUE
• Type of Device: ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
• Manufacturer (Section D): HERAEUS KULZER GMBH; gruner weg 11; hanau, D-63 450; GM D-63450
• Manufacturer (Section G): HERAEUS KULZER GMBH; gruner weg 11; hanau, D-63 450; GM D-63450
• Manufacturer Contact: audi bogucki ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 3567333
• MDR Text Key: 4048145
• Report Number: 3005665377-2014-00003
• Device Sequence Number: 1
• Product Code: EBZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Dental Assistant
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: 66017507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/11/2013
• Device Age: 20 MO
• Date Manufacturer Received: 12/11/2013
• 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
• Patient Outcome(s): Required Intervention