Events

Rappel de IPS CASEDESIGNER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par NOBEL BIOCARE CANADA INC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    96899
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-12-11
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    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: 1.A surgery is planned in the version 1.2 of ips casedesigner using the maxilla rotation point function - moving it from its default position. 2. the user updates the software to the version 1.3. 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version 1.2 with the version 1.3: the maxilla rotation point will move back to its default position changing the plan originally made by the user. 4. the user saves the planning in the version 1.3. 5. 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 sfotware 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.

Device

IPS CASEDESIGNER
  • Modèle / numéro de série
    Model Catalog: 300011_V1.3_MAC (Lot serial: K0000022); Model Catalog: 300011_V1.3_WIN64 (Lot serial: K0000022)
  • Description du dispositif
    IPS CaseDesigner
  • Manufacturer
    NOBEL BIOCARE CANADA INC

Manufacturer

NOBEL BIOCARE CANADA INC