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	Lack of Effect (4065)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
In this event it is reported that ah plus export 3ml china that was used in a root canal treatment in december of 2023 and no abnormalities were reported.In august of 2024 the patient came into the hospital and reported experiencing pain in their teeth.The doctor found periapical periodontitis, secondary caries and tooth defects.Another root canal was done on the same tooth.The patient currently has no abnormalities.A patient reportedly presented pain on an endodontically treated tooth seven months after treatment.They had to undergo endodontic retreatment, which led to improvement in symptoms.The event description suggests a failure of the endodontic treatment, which is a common complication of endodontic treatment and not necessarily related to the sealer.
Additional Manufacturer Narrative
Investigation results: retain: the retained sample was examined on (b)(6) 2024.The results are within specification and are located under (b)(4).The identity of the retained sample was determined using ir spectrum.The identity of the material of the tubes (amin & epoxid) corresponds to the reference samples.Dhr the dhr of the complained batch was checked.There were no abnormalities in the dhr.

• 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: 20783546
• Report Number: 8010638-2024-00012
• Device Sequence Number: 12999088
• 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): 12/09/2024

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: 2404000315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/21/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown