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

Catalog Number	606.20.115
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Too Soft/Flexible (4007)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 8010638-2024-00002
• Device Sequence Number: 20770770
• Product Code: KIF
• UDI-Device Identifier: D010606201151
• UDI-Public: D010606201151
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown