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

Catalog Number 606.20.115

Device Problems Loss of or Failure to Bond (1068); Material Too Soft/Flexible (4007)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Event Description

In this event it is reported that ah plus jet starter kit was used in treatment of 2 patients.Reportedly, complications and post operative pain was reported after use of this product.One patient is still taking medication due to infection.The physician reports that the problem could be with the yellow past and the white paste appeared in the mixer and the consistency was soft and taking longer to set.Additional information has been requested.

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.

Manufacturer Narrative

Investigation: the material identity of the tubes ("amin & epoxid") corresponds to the reference samples.The consistency and the setting behavior of the material are okay.The mixing tip also works perfectly.No abnormalities.The assessment is not applicable to this complaint.Dhr: 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: 18825035
• MDR Text Key: 336738557
• Report Number: 8010638-2024-00002
• Device Sequence Number: 1
• Product Code: KIF
• UDI-Device Identifier: D010606201151
• UDI-Public: D010606201151
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 03/26/2024

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 Catalogue Number: 606.20.115
• Device Lot Number: 2305000716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/28/2024
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1