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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KULZER GMBH VENUS SYR 1 X 4G-A2 DENTAL COMPOSITE, RESIN DEVICES

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KULZER GMBH VENUS SYR 1 X 4G-A2 DENTAL COMPOSITE, RESIN DEVICES Back to Search Results
Catalog Number 66007367
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hair Loss (1877); Low Blood Pressure/ Hypotension (1914); Rash (2033); Thyroid Problems (2102); Discomfort (2330); Malaise (2359); Sensitivity of Teeth (2427); Irregular Pulse (2469)
Event Date 02/06/2018
Event Type  Injury  
Manufacturer Narrative
This incident is reportable according to 21 cfr 803. The fda defines this as a serious injury(21 cfr sec. 803. 3) as the office staff reported the patient having an allergic type reaction. The patient has a confirmed allergy to tegdma, which is an ingredient in the venus composite. The incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution. Overall, kulzer is producing and selling more than 26 million fillings per year. The frequency of occurrence of such an incident is very rare, which means less than one similar issue per one million treatments. The severity of this patient's symptoms are quite strong but strange and unusual in their own way. An anamnesis was done by the dentist, the method (energetic biocompatibility testing) is questionable and the indication of the used product stretched and not supported by kulzer. Therefore, it is the dentist's own responsibility to use the product this way. He is the treating and finally responsible healthcare professional beyond the ifu.
 
Event Description
This event took place near (b)(6). On (b)(6) 2018 - treated region 35, seating of ceramic-inlay. On (b)(6) 2018 - test of dental material at dental surgery. Result, material used for treatment: durelon (temp. Filling) and venus as bonding agent for the inlay. On (b)(6) 2018 - bonding of ceramic inlay using venus-patient experienced an allergic reaction. Two additional appointments on (b)(6) 2018 and (b)(6) 2018: although venus was removed, the symptoms only subsided a little. The inlay has been replaced (glass ionomer) tooth cement filling, which abraded and dissolved within a few weeks. The patient consulted an additional dentist and the tooth was treated painlessly. The symptoms obviously did not disappear. Since (b)(6) 2018 the patient suffers from several symptoms: tooth ache, skin rash accompanied by permanent pain, difficulties with several organs (in particular kidney and lung), hair loss, pressure on thyroid, low blood pressure combined with accelerated pulse and listlessness. Meanwhile, the physical symptoms decreased (due to lots of treatments) but the psychological stress remains. Patient anamnesis: intolerances for metals, plastics and adrenalin. Allergy testing: energetic biocompatibility testing. And venus was agreed for cementation of a full ceramic inlay. After insertion of the inlays: no intraoral symptoms, but symptoms elsewhere as described above. Inlays were removed 14 days after insertion and the cavity was closed with a dental (glass ionone?) cement; no medical treatment by the dentist; no drugs prescribed. Treatments by a second dentist and other health care professional, were not specified in detail, therefore no other treatments are known. In (b)(6) 2018, the patient saw prof. (b)(6) from the dental toxicology of the university of (b)(6). He confirmed the patient's allergic disposition to chromium, nickel, benzoyl peroxide and tegdma. Tegdma is a component of the venus composite compound.
 
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Brand NameVENUS SYR 1 X 4G-A2
Type of DeviceDENTAL COMPOSITE, RESIN DEVICES
Manufacturer (Section D)
KULZER GMBH
leipziger strasse 2
hanau, 63450
GM 63450
Manufacturer (Section G)
KULZER GMBH
philipp-reis-strasse 8/13
wehrheim, 61273
GM 61273
Manufacturer Contact
albert erdrich
leipziger strasse 2
hanau, hesse 63450
GM   63450
MDR Report Key8849564
MDR Text Key152948675
Report Number9610902-2019-00010
Device Sequence Number1
Product Code EBF
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K020131
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Dentist
Type of Report Initial
Report Date 08/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/10/2020
Device Catalogue Number66007367
Device Lot NumberK010509
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/01/2019 Patient Sequence Number: 1
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