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Patients at risk due to fake Mtwo instruments

Fake Mtwo instruments have been discovered in a dental practice. The quality of these products is significantly different from that of the original made by the manufacturer, VDW in Munich. At first glance, the fakes are not easy to identify as the blister packaging and labels are almost identical to the original. As two incidents involving the treatment of patients have already been reported, it is critical to urgently warn dentists against the use of fake products.

The fake instruments have a larger diameter than the original instruments (Fig. 1, measured at 9 mm from the tip). This not only reduces the depth of the flutes (deep flutes prevent debris from accumulating in the canal) but also the flexibility of the instrument. Hence, they are more stiff. Further testing shows that the fakes have an average of 40% less bending strength than the originals.

This rigidity increases the risks of creating ledges (no uniform conical shape of canal) and the shifting of the canal axis in curved canals.

Cutting edges and blades of the fake are significantly less clear-cut than the original. Flutes for the removal of dentine debris are also shallower (higher risk of debris accumulation in the canal/).

The design of the instrument tip deviates significantly from the original (Fig. 2, ISO size 25/04) which may result in incomplete preparation (reduced working length).

At 3 mm and 13 mm from the tip, the diameters often exceed the permissible production tolerance limit. Hence, the instrument sizes do not correspond with their ISO sizes, which will result in the over-preparation of the root canal and difficult fitting of gutta-percha cones for obturation.

The fake instruments are on average17% less resistant to fatigue than the originals, posing a higher risk of instrument (fatigue) fractures.

Investigations are currently underway in an external special laboratory to determine if the fake instruments are sterile as stated on their packaging. This information will be provided shortly.

According to the dental practice, the fake instruments were supplied by the company, Pluradent. VDW contacted Pluradent right after receiving news from the dental practice. Latest information: Pluradent has immediately contacted all its customers who received fake Mtwo products and  has offered to exchange the fakes for original Mtwo instruments. In addition, Pluradent has promptly revealed the sources from which they received the fake products. This enables VDW to take legal actions against the suppliers of the fake products and to hopefully stop the circulation of fakes on the market.

At present, it is still unclear if other dental dealers have also introduced fake Mtwo instruments onto the market.

We recommend all Mtwo users to make sure that their dental dealers get their instruments directly from VDW Munich. Only through direct purchasing from the manufacturer, customers can guarantee that they receive original products.

Keep up-to-date on www.vdw-dental/falsifikate.

Contact: VDW customer careTel. + 49 89 62734-555

Patients at risk due to fake Mtwo instruments

Fake Mtwo instruments have been discovered in a dental practice in Schleswig-Holstein. The quality of these products is significantly different from that of the original made by the manufacturer, VDW in Munich. At first glance, the fakes are not easy to identify as the blister packaging and labels are almost identical to the original. As two incidents involving the treatment of patients have already been reported, it is critical to urgently warn dentists against the use of fake products.

According to the dental practice, the fake instruments were supplied by the company, Pluradent. The company has been contacted for more detailed information. The instruments affected are the sizes10/.04, 25/.06, 30/.05 and 35/.04 in 25 mm working length. However, it is not possible to rule out the fact that other sizes/lengths may have been faked as well. Cutting edges and blades of the fakes are significantly less clear-cut than the original. Flutes for the removal of dentine debris (prevention of debris accumulation in the canal) are also shallower. The diameters exceed the permissible production tolerance limit and the instrument tips are spade-shaped and much too wide. This may, for example, lead to incomplete preparation (reduced working length) with a significantly higher risk of instrument fracture. Please refer to www.vdw-dental.com/falsifikate for further details and images.

The manufacturer, VDW, is offering customers the service of checking the authenticity of their Mtwo instruments.

Contact:
VDW Customer Care
Tel. +49 89 62734-555

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