MAUDE Adverse Event Report: DENTSPLY DETREY GMBH AH PLUS JET REFILL KIT; RESIN, ROOT CANAL FILLING

Catalog Number 60620118

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 06/25/2015

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested, but is not yet available.Based on the chemical and physical properties of paste b, it can be concluded that patients where paste b of ah plus was used as a root canal sealer only may experience issues up to and including loss of the treated tooth.It is recommended that the patients treated with the faulty syringe be examined clinically and radiologically and consider retreatment of the affected root canal fillings.Therefore, because medical intervention may be required, this event is reportable per 21 cfr part 803.Investigation found a manufacturing error that resulted in both chambers of the syringe to be filled with paste b.

Event Description

In this event it was reported that only paste b was coming out of an ah plus jet syringe.The syringe was used on an unknown number of patients.No patient details are available as of this mdr evaluation.

Manufacturer Narrative

After a comprehensive investigation, it was found that only a single syringe was faulty and the complete lot was not affected.This issue was caused by a human error during the set-up of the equipment.

• Brand Name: AH PLUS JET REFILL KIT
• Type of Device: RESIN, ROOT CANAL FILLING
• Manufacturer (Section D): DENTSPLY DETREY GMBH; konstanz ; GM
• Manufacturer Contact: helen lewis ; susquehanna commerce ctr w.; 221 w. philadelphia st., ste. 60; york, PA 17401 ; 7178457511
• MDR Report Key: 5008538
• MDR Text Key: 23217616
• Report Number: 8010638-2015-00008
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K960548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Followup
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 60620118
• Device Lot Number: 1412000549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2015
• 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