MAUDE Adverse Event Report: KULZER GMBH - HQ VENUS BULK FLOW SYR 1 X 2G ONE; MATERIAL, TOOTH SHADE, RESIN

Catalog Number	66094723
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This incident is reportable according to 21 cfr 803.The code states: serious injury means an injury or illness that: (1) is life-threatening, (2) results in permanent impairment of a body function or permanent damage to a body structure, or (3) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.On (b)(6) 2024 a patient reported to her dentist that she had difficulty breathing and discomfort after a filling was placed.The patient has a known nickel allergy.Nickel is not an ingredient in venus bulk flow one.The patient has a history of smoking and hypertension.The dentist recommended the patient to see her family doctor and have an ecg performed.We evaluated this complaint and deemed it not reportable at the time.On (b)(6) 2024 new information was received that the patient had the tooth extracted, at their own request, by a surgeon.The history of the tooth was provided: previous endodontic treatment (root canal therapy), an amalgam filling that was replaced with the composite, venus bulk flow one.The treating dentist claims that he cannot see a connection between the composite filling and the tooth extraction.Additionally, he is currently not aware of any further treatment necessary because of the extracted tooth.Although there is no causal relationship between the product used and the tooth loss, a complete exclusion of any connection is not possible.A tooth extraction (loss of a tooth) is considered a serious incident, and therefore will be reported to the fda accordingly.
Event or Problem Description
Manufacturer awareness date of reportability: 18.09.2024.A dentist informed kulzer customer service that a female patient (64 years old, treated hypertension, with a history of smoking) complained about ongoing symptoms of discomfort and more difficult breathing developed at home in the evening after a filling treatment.The dentist was informed about the symptoms from the patient on day 4 after the treatment.The patient is allergic to nickel, which is not added to the products.Patient has probably been prone to allergies for a while (one year).The dentist pointed out that it was very hot on the day of the treatment.A root canal-treated tooth (37) was treated for the replacing of an amalgam filling.The tooth prognosis at this date is unknown.We are therefore unable to assess why the patient wants the tooth extracted.On (b)(6) 2024 the dentist informed that the tooth has been extracted by an oral surgeon at the patient's request.The cause (medical indication) for the extraction is unknown.The dentist suspects that the symptoms have not been due to the filling rather to the outside heat.Nevertheless an allergy testing has been recommended, which the patient refused.

• Brand Name: VENUS BULK FLOW SYR 1 X 2G ONE
• Common Device Name: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): KULZER GMBH - HQ; leipziger strasse 2; hanau, hesse 63450 ; GM 63450
• Manufacturer (Section G): KULZER GMBH - WEHRHEIM; philipp-reis-strasse 8/13; wehrheim, hesse 61273 ; GM 61273
• Manufacturer Contact: matthias hartmann ; leipziger strasse 2; hanau, hesse 63450 ; GM 63450
• MDR Report Key: 20415039
• Report Number: 3005665377-2024-00002
• Device Sequence Number: 15600733
• Product Code: EBF
• UDI-Device Identifier: J014660947230
• UDI-Public: +J014660947230/$$3271016N010033/16D202404165
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K220605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/10/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 66094723
• Device Lot Number: N010033
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/10/2024
• Date Device Manufactured: 04/16/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IBOND TOTAL ETCHOMNIDENT ETCHANT (PRISMAN GMBH)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female