Investigation into the malfunction found that the fixation point was placed too close to the building block in the 3d print causing a mechanical deficiency in one fixation arm when the support material was manually removed.During the investigation it was also discovered that the orientation of the titanium mesh, in relation to the building block, could have introduced further mechanical deficiencies in the given fixation arm as the support structure added to maintain it mechanical stability did not fully fulfil its intended use.This resulted in a fixation arm breakage during shipment of the device.The mechanical properties of the implanted device have been reviewed and found sufficient for its intended use.The remaining 5 fixation arms are not affected by the deficiency and sufficient to maintain the implant's position.The found manufacturing deficiencies have been addressed.
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