MAUDE Adverse Event Report: DENTSPLY DETREY GMBH AH PLUS JET START.KIT MAIL.NA; RESIN, ROOT CANAL FILLING

Catalog Number	667005
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Numbness (2415); Caustic/Chemical Burns (2549)
Date of Event	10/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event it is reported that ah plus jet start kit mail.Na that was used in treatment had a malfunction with the auto mixing tip.The unmixed sealer went out of the apex and reportedly caused a chemical burn of patient's mental nerve - right side of face.The patient reportedly developed numbness in the right half of the chin and lower lip and pain on the whole right side of their face two days after exposure to ah plus jet during root canal treatment.The symptoms are still ongoing.The dentist alleges this was due to an issue with the auto-mixing tip, which would not have mixed the product correctly, in turn leading to unmixed material coming into contact with the nerve and causing a chemical burn.Customer/dentist reports that this was not an allergic reaction.
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 is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Additional Manufacturer Narrative
Investigation results: retain: retained sample was examined.Results are within specification and can be found in the attachment.The assessment is not applicable to this complaint.Dhr: the dhr of the complained batch was checked.There were no abnormalities in the dhr.Failure mode: possible allergic reaction.

• Brand Name: AH PLUS JET START.KIT MAIL.NA
• 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: 17967638
• Report Number: 8010638-2023-00028
• Device Sequence Number: 6799757
• Product Code: KIF
• UDI-Device Identifier: D0106670051
• UDI-Public: D0106670051
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-1976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

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: 667005
• Device Lot Number: 2201001043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/05/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown