Health Canada — Medical Devices · Canada · 2013-12-04 · Type I
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Reported risk: When using the Osseocare Pro Ipad application release 1.2.0.7, the grey button located on the foot pedal has no effect on the rotation direction. Pressing the grey button normally sets the motor in reverse rotation mode. However, when pressing the grey button with the software release 1.2.0.7, this does not change the rotation direction. This malfunction may result in the screw tap and/or implant being placed deeper than intended, which in the worst case could damage vital anatomical structures (Mandibular nerve and blood vesseles, or penetration in to the Lumen of maxillary sinus or nasal cavity).
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