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

Catalog Number 606.20.115

Device Problems Overfill (2404); Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

Event Description

In this event it is reported ah plus jet starter after injection of filling material into root canal the patient felt pain.The root canal was cleaned out and rinsed with solution to relieve patient's pain.

Manufacturer Narrative

Investigation results: the dhr of the complained batch was checked.There were no abnormalities in the dhr.

• Brand Name: AH PLUS JET STARTER KIT
• Type of Device: RESIN, ROOT CANAL FILLING
• Manufacturer (Section D): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz baden-wurttemberg 78467 ; GM 78467
• Manufacturer (Section G): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz baden-wurttemberg 78467 ; GM 78467
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 15553324
• MDR Text Key: 306503355
• Report Number: 8010638-2022-00016
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 606.20.115
• Device Lot Number: 2109001083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/28/2022
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2021
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Male