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Serious injury includes- injury that is life-threatening, results in permanent impairment, or damage to body function/structure, or requires medical or surgical intervention to prevent permanent impairment/damage. Contributed- events resulting from failure, malfunction, use error, improper design, inadequate labeling. Malfunction- the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include relevant claims made in the labeling of the device.