[A] plaintiff must allege specific facts as to how a manufacturer violated federal requirements and the causal connection between such violations and the plaintiff’s injuries to survive a motion to dismiss. . . In this case, [plaintiff] makes conclusory allegations concerning defects in [the] manufacturing process, but does not include any factual support as to how [defendant] failed to manufacture the [device] in the manner required by the PMA process.
The Amended Complaint is further devoid of any factual allegations concerning the actual condition or observation of the device upon its removal which may possibly provide the required causal connection.