Study: NCT00578812

Adverse event: Implant Related-Adjacent Level Disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 214 at risk

Adverse event: Implant Related - Implant Displacement/Loosening
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 214 at risk

Adverse event: Implant Related - Spinal Event
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 214 at risk

Adverse event: Implant Related - Subsidence
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 214 at risk

Adverse event: Implant Related - Trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 214 at risk

Adverse event: Surgery Related - Neck/Arm Pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 214 at risk

Adverse event: Surgery Related - Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 214 at risk

Adverse event: Systemic - Cardiac Events
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 214 at risk

Adverse event: Systemic- Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 214 at risk

Adverse event: Systemic - Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 214 at risk

Adverse event: Systemic - Musculoskeletal Trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 214 at risk

Adverse event: Systemic - Musculoskeletal Adjacent Level Disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 214 at risk

Adverse event: Systemic - Musculoskeletal / Back/Leg Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 214 at risk

Adverse event: Systemic - Musculoskeletal / Neck/Arm Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 214 at risk

Adverse event: Systemic - Musculoskeletal / Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 214 at risk

Adverse event: Systemic - Musculoskeletal / Spinal Event
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 214 at risk

Adverse event: Systemic - Other
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 214 at risk

Adverse event: Implant Related - Adjacent Level Disease
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 214 at risk

Adverse event: Implant Related - Spinal Event
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 214 at risk

Adverse event: Surgery related - dysphagia/dysphonia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 214 at risk

Adverse event: Surgery related - Incision Site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 214 at risk

Adverse event: Surgery Related - Neck / Arm Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 21 affected / 214 at risk

Adverse event: Surgery Related - Neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 214 at risk

Adverse event: Systemic - Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 214 at risk

Adverse event: Systemic - Infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 214 at risk

Adverse event: Systemic - Musculoskeletal Trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 42 affected / 214 at risk

Adverse event: Systemic - Musculoskeletal / Back/Leg Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 36 affected / 214 at risk

Adverse event: Systemic - Musculoskeletal / Neck/Arm Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 87 affected / 214 at risk

Adverse event: Systemic - Musculoskeletal / Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 214 at risk

Adverse event: Systemic - Musculoskeletal / Spinal Event
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 214 at risk

Adverse event: Systemic - Neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 214 at risk

Adverse event: Systemic - Other
Serious: no
Organ System: General disorders
Frequency: 42 affected / 214 at risk

Adverse event: Implant Related - Implant Displacement/Loosening
Serious: no
Organ System: Investigations
Frequency: 10 affected / 214 at risk

Adverse event: Implant Related - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 214 at risk

Adverse event: Implant Related - Radiolucency
Serious: no
Organ System: Investigations
Frequency: 3 affected / 214 at risk

Adverse event: Implant Related - Subsidence
Serious: no
Organ System: Investigations
Frequency: 1 affected / 214 at risk

Adverse event: Implant Related - Trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 214 at risk

Adverse event: Surgery Related - Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 214 at risk

Adverse event: Surgery Related - Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Surgery Related - Other
Serious: no
Organ System: General disorders
Frequency: 4 affected / 214 at risk

Adverse event: Surgery Related - Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Surgery Related - Spinal Event
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 214 at risk

Adverse event: Surgery Related - Vertebral Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 214 at risk

Adverse event: Systemic - Cardiac Events
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 214 at risk

Adverse event: Systemic - Dysphagia/Dysphonia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 214 at risk

Adverse event: Systemic - Mental Disorder
Serious: no
Organ System: General disorders
Frequency: 2 affected / 214 at risk

Adverse event: Systemic - Musculoskeletal/Adjacent Level Disease
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 214 at risk

Adverse event: Systemic - Other Trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 214 at risk

Adverse event: Systemic - Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 214 at risk

Adverse event: Systemic - Urogenital
Serious: no
Organ System: General disorders
Frequency: 2 affected / 214 at risk

Adverse event: Implant Related-Adjacent Level Disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 190 at risk

Adverse event: Implant Related - Non Union
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 190 at risk

Adverse event: Implant Related - Trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 190 at risk

Adverse event: Surgery Related - Neck/Arm Pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 190 at risk

Adverse event: Surgery Related - Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 190 at risk

Adverse event: Surgery Related - Spinal Event
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 190 at risk

Adverse event: Systemic - Cardiac Events
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 190 at risk

Adverse event: Systemic- Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 190 at risk

Adverse event: Systemic - Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 190 at risk

Adverse event: Systemic - Mental Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 190 at risk

Adverse event: Systemic - Musculoskeletal Trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 190 at risk

Adverse event: Systemic - Musculoskeletal / Back/Leg Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 190 at risk

Adverse event: Systemic - Musculoskeletal / Neck/Arm Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 190 at risk

Adverse event: Systemic - Musculoskeletal / Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 190 at risk

Adverse event: Systemic - Musculoskeletal / Spinal Event
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 190 at risk

Adverse event: Systemic - Neurologic
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 190 at risk

Adverse event: Systemic - Other
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 190 at risk

Adverse event: Systemic - Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 190 at risk

Adverse event: Systemic - Urogenital
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 190 at risk

Adverse event: Implant Related - Adjacent Level Disease
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 190 at risk

Adverse event: Implant Related - Non Union
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 190 at risk

Adverse event: Implant Related - Spinal Event
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 190 at risk

Adverse event: Surgery related - dysphagia/dysphonia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 23 affected / 190 at risk

Adverse event: Surgery related - Incision Site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 190 at risk

Adverse event: Surgery Related - Neck / Arm Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 32 affected / 190 at risk

Adverse event: Surgery Related - Neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 190 at risk

Adverse event: Systemic - Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 190 at risk

Adverse event: Systemic - Infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 190 at risk

Adverse event: Systemic - Musculoskeletal Trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 32 affected / 190 at risk

Adverse event: Systemic - Musculoskeletal / Back/Leg Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 33 affected / 190 at risk

Adverse event: Systemic - Musculoskeletal / Neck/Arm Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 68 affected / 190 at risk

Adverse event: Systemic - Musculoskeletal / Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 190 at risk

Adverse event: Systemic - Musculoskeletal / Spinal Event
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 190 at risk

Adverse event: Systemic - Neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 190 at risk

Adverse event: Systemic - Other
Serious: no
Organ System: General disorders
Frequency: 26 affected / 190 at risk

Adverse event: Implant Related - Implant Displacement/Loosening
Serious: no
Organ System: Investigations
Frequency: 1 affected / 190 at risk

Adverse event: Implant Related - Neck/Arm Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 190 at risk

Adverse event: Implant Related - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 190 at risk

Adverse event: Implant Related - Radiolucency
Serious: no
Organ System: Investigations
Frequency: 3 affected / 190 at risk

Adverse event: Implant Related - Subsidence
Serious: no
Organ System: Investigations
Frequency: 2 affected / 190 at risk

Adverse event: Implant Related - Trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 190 at risk

Adverse event: Surgery Related - Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 190 at risk

Adverse event: Surgery Related - Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 190 at risk

Adverse event: Surgery Related - Other
Serious: no
Organ System: General disorders
Frequency: 7 affected / 190 at risk

Adverse event: Surgery Related - Spinal Event
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 190 at risk

Adverse event: Surgery Related - Urogenital
Serious: no
Organ System: General disorders
Frequency: 2 affected / 190 at risk

Adverse event: Systemic - Cardiac Events
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 190 at risk

Adverse event: Systemic - Dysphagia/Dysphonia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 190 at risk

Adverse event: Systemic - Mental Disorder
Serious: no
Organ System: General disorders
Frequency: 4 affected / 190 at risk

Adverse event: Systemic - Musculoskeletal/Adjacent Level Disease
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 190 at risk

Adverse event: Systemic - Other Trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 190 at risk

Adverse event: Systemic - Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 190 at risk

Adverse event: Systemic - Urogenital
Serious: no
Organ System: General disorders
Frequency: 8 affected / 190 at risk