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

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.

• Brand Name: VENUS SYR 1 X 4G-A2
• Type of Device: DENTAL 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 Key: 8849564
• MDR Text Key: 152948675
• Report Number: 9610902-2019-00010
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K020131
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2020
• Device Catalogue Number: 66007367
• Device Lot Number: K010509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 08/01/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Other