MAUDE Adverse Event Report: DENTSPLY DETREY GMBH AH PLUS EXPORT 3ML CHINA; RESIN, ROOT CANAL FILLING

Catalog Number	606.20.113
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr 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 or Problem Description
In this event it is reported that ah plus export 3ml china, the paste was thin and the gutta-percha point cannot solidify and the root canal became inflamed, requiring second treatment.
Additional Manufacturer Narrative
Investigation results no customer samples was sent in.For this reason, tests were carried out on retained samples.The material identity of the tubes ("amin & epoxid") corresponds to the reference samples.The consistency and the setting behavior of the material are okay and within specification.No abnormalities.A systematic error can be excluded.The investigation did not confirm the reason for the complaint.Dhr the dhr of the complained batch was checked.There were no abnormalities in the dhr.Failure mode- setting improperly/not setting root cause handling issue conclusion code- indeterminable.

• Brand Name: AH PLUS EXPORT 3ML CHINA
• 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 20368134
• Report Number: 8010638-2024-00009
• Device Sequence Number: 19755360
• Product Code: KIF
• UDI-Device Identifier: D010606201101
• UDI-Public: D010606201101
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/07/2024

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?: No
• Device Catalogue Number: 606.20.113
• Device Lot Number: 240400043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/29/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown