Medical device manufacturer, Nobel Biocare issued a medical device safety alert concerning NobelClinician Software version 1.1-1.3.
Nobel Biocare has received a complaint on the surgical template not matching the planning software regarding sleeve diameter. After investigation, it was discovered that a bug is causing the mismatch. The event concerns when a size NobelActive RP implant is planned to be used and the implant diameter is changed. If the change is not done through the conventional 'Product Selection Dialog', the sleeve in the surgical template will not update and will correspond to the size of the originally selected implant. The resulting surgical template will have sleeves that can be too small or too big for the instruments.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 July 2012