Health Canada — Medical Devices · Canada · 2018-01-08 · Type II
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Reported risk: A bug has been discovered via a support case for the IPS Casedesigner Software on November 24, 2017, which might lead to designing an incorrect intermediate splint and the user to place the maxilla (and as a result of the occlusion matching, also the mandibula) incorrectly during surgery in a very specific scenario: A Surgery is planned in the Version 1.2 Of IPS Casedesigner, Using the Maxilla Rotation Point Function - Moving It from Its Default Position. The User updates the software to the Version 1.3. The User Opens the Planning Previously Made in The Version 1.2 With the Version 1.3: The Maxilla Rotation Point Will Move Back to Its Default Position, Changing the Plan Originally Made by The User. The User Saves the Planning in The Version 1.3. The User Orders the Splints (Intermediate and Final) According to The Revised Planning Without Noticing the Change. The modification of the surgery planning by the software due to the buy can only be detected if the change to the original planning is obvious. The user should always carefully check the surgery planning before proceeding to creating the surgical splint file. A total 37 articles were deployed to 20 customers. Only one article, 300011_v1.3_win64, was sold in Canada.
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