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

Catalog Number 60620115

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

In this event it was reported that a patient had pain several days after treatment with ah plus jet.The dentist removed the material from the patient's root canal and found it was still fluid.One day after the material was removed, the patient's pain disappeared.

Manufacturer Narrative

Upon review of the dentist's technique, it was found that he did not follow the dfu and bleed the material before use.Therefore, because intervention was required, this event is reportable per 21 cfr part 803.The device was evaluated and found to be within specification.A dhr review was conducted with no discrepancies noted.

• Brand Name: AH PLUS JET SEALER
• Type of Device: ROOT CANAL FILLING RESIN
• 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: 4821450
• MDR Text Key: 5839539
• Report Number: 8010638-2015-00005
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Initial
• Report Date: 05/04/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 60620115
• Device Lot Number: 1408000785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2015
• Initial Date FDA Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MIXING TIPS, AH TEMP.
• Patient Outcome(s): Required Intervention