<qa>  What is the name of the adverse event that is defined as?Adverse events Adverse events are defined as any harmful and unwanted event, sign or symptom to occur in relation to this trial. All adverse events will be recorded in the CRF and will include details concerning the nature, onset, duration, severity, relationship to the device and relationship to the operative procedure and outcome. The affected patients will be questioned about any adverse events at each subsequent follow-up visit. 