Study: NCT00389597

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: All reported of AEs of cancer (malignancy or malignant tumor/neoplasm)
Frequency: 1 affected / 179 at risk

Adverse event: Anatomy/Technical Difficulty
Serious: yes
Organ System: Surgical and medical procedures
Notes: Anatomy/Technical Difficulty includes Cervical - Study Surgery, Cervical - Non Study Surgery and Non Cervical
Frequency: 1 affected / 179 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 179 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 179 at risk

Adverse event: Extraskeletal ossification
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Heterotopic Ossification includes Cervical - Index Level, Cervical - Adjacent Level and Non Cervical
Frequency: 1 affected / 179 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Infection includes Superficial Wound - Cervical, Deep Wound - Cervical, Other Wound - Non Study Surgery, both Systemic and Local
Frequency: 3 affected / 179 at risk

Adverse event: Malpositioned implant
Serious: yes
Organ System: Surgical and medical procedures
Notes: includes misplaced screw, subsidence, a sub optimal or undesired position, regardless of causality. This is not mutually exclusive to surgeon error or sub-optimal placement of the original implant configuration.
Frequency: 1 affected / 179 at risk

Adverse event: Neck and/or Arm Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Neck and/or Arm Pain includes pain (and related pain terms) specific to neck (cervical spine) and arm pain (and related pain terms) specific to arm (spinal disorders are recorded elsewhere).
Frequency: 3 affected / 179 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Notes: Neurological including Upper Extremity - Sensory, motor, reflex; Lower Extremity - Sensory, motor, reflex; Upper \& Lower Extremity - Sensory, motor, reflex; neck, back, spinal cord disturbance; gait disturbance, non specific and other
Frequency: 5 affected / 179 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: includes Blood/Lymphatic, Congenital/Genetic, Ear/Labyrinth, Endocrine, Eye, Immune, Metabolism/Nutrition, Musculoskeletal /CT, Benign Neoplasm, Nervous, Psychiatric, Repro, Skin, Vascular , Poisoning, Pregnancy, Social \& surgical/Medical procedures
Frequency: 6 affected / 179 at risk

Adverse event: Other pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Other Pain including Shoulder, Back, Torso, Lower Extremity, Headache, Other
Frequency: 6 affected / 179 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 179 at risk

Adverse event: Spinal disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Spinal Disorder including Cervical - Study Surgery, Cervical - Non Study Surgery and Non Cervical
Frequency: 3 affected / 179 at risk

Adverse event: Injury
Serious: yes
Organ System: Social circumstances
Notes: includes falls, motor vehicle accidents, assault, injury, etc. This category includes both cervical and non-cervical AEs of Trauma.
Frequency: 4 affected / 179 at risk

Adverse event: Urogenital
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 179 at risk

Adverse event: Upper Extremity Nerve Entrapment
Serious: yes
Organ System: Nervous system disorders
Notes: including all reported AEs of Carpel Tunnel Syndrome and Cubital Tunnel Syndrome, including AEs directly attributed to Carpel Tunnel Syndrome or Cubital Tunnel Syndrome, as well as Carpal Tunnel surgery.
Frequency: 3 affected / 179 at risk

Adverse event: Anatomy/Techical Difficulty
Serious: no
Organ System: Surgical and medical procedures
Frequency: 11 affected / 179 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 179 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 179 at risk

Adverse event: Dysphagia/Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 179 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 179 at risk

Adverse event: Extraskeletal ossification
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 179 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 179 at risk

Adverse event: Malpositioned Implant
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 179 at risk

Adverse event: Neck and/or Arm Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 101 affected / 179 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 121 affected / 179 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 77 affected / 179 at risk

Adverse event: Other Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 102 affected / 179 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 179 at risk

Adverse event: Spinal disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 179 at risk

Adverse event: Injury
Serious: no
Organ System: Social circumstances
Frequency: 47 affected / 179 at risk

Adverse event: Upper Extremity Nerve Entrapment
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 179 at risk

Adverse event: Urogenital
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 179 at risk

Adverse event: Vascular Intraoperative
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 179 at risk

Adverse event: Wound Issue -- Non-Infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 179 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: All reported of AEs of cancer (malignancy or malignant tumor/neoplasm)
Frequency: 1 affected / 81 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 81 at risk

Adverse event: Dysphagia/Dysphonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: includes all reported AEs of Dysphagia and other terms consistent with "difficulty swallowing" and all reported AEs of Dysphonia and other terms consistent with "voice change and/or disruption".
Frequency: 1 affected / 81 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 81 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Infection includes Superficial Wound - Cervical, Deep Wound - Cervical, Other Wound - Non Study Surgery, both Systemic and Local
Frequency: 4 affected / 81 at risk

Adverse event: Malpositioned implant
Serious: yes
Organ System: Surgical and medical procedures
Notes: includes misplaced screw, subsidence, a sub optimal or undesired position, regardless of causality. This is not mutually exclusive to surgeon error or sub-optimal placement of the original implant configuration.
Frequency: 1 affected / 81 at risk

Adverse event: Neck and/or Arm Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Neck and/or Arm Pain includes pain (and related pain terms) specific to neck (cervical spine) and arm pain (and related pain terms) specific to arm (spinal disorders are recorded elsewhere).
Frequency: 2 affected / 81 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Notes: Neurological including Upper Extremity - Sensory, motor, reflex; Lower Extremity - Sensory, motor, reflex; Upper \& Lower Extremity - Sensory, motor, reflex; neck, back, spinal cord disturbance; gait disturbance, non specific and other
Frequency: 3 affected / 81 at risk

Adverse event: Non-union
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-Union includes non-union, cervical fusion failure, pseudoarthrosis, and pending non-unions as reported ; limited to study surgery related events of non-union.
Frequency: 5 affected / 81 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: includes Blood/Lymphatic, Congenital/Genetic, Ear/Labyrinth, Endocrine, Eye, Immune, Metabolism/Nutrition, Musculoskeletal /CT, Benign Neoplasm, Nervous, Psychiatric, Repro, Skin, Vascular , Poisoning, Pregnancy, Social \& surgical/Medical procedures
Frequency: 1 affected / 81 at risk

Adverse event: Other pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Other Pain including Shoulder, Back, Torso, Lower Extremity, Headache, Other
Frequency: 4 affected / 81 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 81 at risk

Adverse event: Spinal disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Spinal Disorder including Cervical - Study Surgery, Cervical - Non Study Surgery and Non Cervical
Frequency: 7 affected / 81 at risk

Adverse event: Injury
Serious: yes
Organ System: Social circumstances
Notes: includes falls, motor vehicle accidents, assault, injury, etc. This category includes both cervical and non-cervical AEs of Trauma.
Frequency: 5 affected / 81 at risk

Adverse event: Upper Extremity Nerve Entrapment
Serious: yes
Organ System: Nervous system disorders
Notes: including all reported AEs of Carpel Tunnel Syndrome and Cubital Tunnel Syndrome, including AEs directly attributed to Carpel Tunnel Syndrome or Cubital Tunnel Syndrome, as well as Carpal Tunnel surgery.
Frequency: 1 affected / 81 at risk

Adverse event: Wound Issue - Non-infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: including Hematoma, Hematoma Evacuation and CSF Leakage
Frequency: 2 affected / 81 at risk

Adverse event: Anatomy/Techical Difficulty
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 81 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 81 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 81 at risk

Adverse event: Dysphagia/Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 81 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 81 at risk

Adverse event: Extraskeletal ossification
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 81 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 81 at risk

Adverse event: Malpositioned Implant
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 81 at risk

Adverse event: Neck and/or Arm Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 47 affected / 81 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 52 affected / 81 at risk

Adverse event: Non-Union
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 81 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 33 affected / 81 at risk

Adverse event: Other Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 47 affected / 81 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 81 at risk

Adverse event: Spinal disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 81 at risk

Adverse event: Injury
Serious: no
Organ System: Social circumstances
Frequency: 20 affected / 81 at risk

Adverse event: Upper Extremity Nerve Entrapment
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 81 at risk

Adverse event: Urogenital
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 81 at risk

Adverse event: Wound Issue -- Non-Infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 81 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: All reported of AEs of cancer (malignancy or malignant tumor/neoplasm)
Frequency: 1 affected / 234 at risk

Adverse event: Anatomy/Technical Difficulty
Serious: yes
Organ System: Surgical and medical procedures
Notes: Anatomy/Technical Difficulty includes Cervical - Study Surgery, Cervical - Non Study Surgery and Non Cervical
Frequency: 1 affected / 234 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 234 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: includes all deaths not related to the device - respiratory, cardiac, etc
Frequency: 1 affected / 234 at risk

Adverse event: Dysphagia/Dysphonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: includes all reported AEs of Dysphagia and other terms consistent with "difficulty swallowing" and all reported AEs of Dysphonia and other terms consistent with "voice change and/or disruption".
Frequency: 2 affected / 234 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 234 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Infection includes Superficial Wound - Cervical, Deep Wound - Cervical, Other Wound - Non Study Surgery, both Systemic and Local
Frequency: 6 affected / 234 at risk

Adverse event: Malpositioned implant
Serious: yes
Organ System: Surgical and medical procedures
Notes: includes misplaced screw, subsidence, a sub optimal or undesired position, regardless of causality. This is not mutually exclusive to surgeon error or sub-optimal placement of the original implant configuration.
Frequency: 1 affected / 234 at risk

Adverse event: Neck and/or Arm Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Neck and/or Arm Pain includes pain (and related pain terms) specific to neck (cervical spine) and arm pain (and related pain terms) specific to arm (spinal disorders are recorded elsewhere).
Frequency: 10 affected / 234 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Notes: Neurological including Upper Extremity - Sensory, motor, reflex; Lower Extremity - Sensory, motor, reflex; Upper \& Lower Extremity - Sensory, motor, reflex; neck, back, spinal cord disturbance; gait disturbance, non specific and other
Frequency: 5 affected / 234 at risk

Adverse event: Non-union
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-Union includes non-union, cervical fusion failure, pseudoarthrosis, and pending non-unions as reported ; limited to study surgery related events of non-union.
Frequency: 1 affected / 234 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: includes Blood/Lymphatic, Congenital/Genetic, Ear/Labyrinth, Endocrine, Eye, Immune, Metabolism/Nutrition, Musculoskeletal /CT, Benign Neoplasm, Nervous, Psychiatric, Repro, Skin, Vascular , Poisoning, Pregnancy, Social \& surgical/Medical procedures
Frequency: 12 affected / 234 at risk

Adverse event: Other pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Other Pain including Shoulder, Back, Torso, Lower Extremity, Headache, Other
Frequency: 10 affected / 234 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 234 at risk

Adverse event: Spinal disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Spinal Disorder including Cervical - Study Surgery, Cervical - Non Study Surgery and Non Cervical
Frequency: 4 affected / 234 at risk

Adverse event: Injury
Serious: yes
Organ System: Social circumstances
Notes: includes falls, motor vehicle accidents, assault, injury, etc. This category includes both cervical and non-cervical AEs of Trauma.
Frequency: 7 affected / 234 at risk

Adverse event: Urogenital
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 234 at risk

Adverse event: Upper Extremity Nerve Entrapment
Serious: yes
Organ System: Nervous system disorders
Notes: including all reported AEs of Carpel Tunnel Syndrome and Cubital Tunnel Syndrome, including AEs directly attributed to Carpel Tunnel Syndrome or Cubital Tunnel Syndrome, as well as Carpal Tunnel surgery.
Frequency: 4 affected / 234 at risk

Adverse event: Wound Issue - Non-infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: including Hematoma, Hematoma Evacuation and CSF Leakage
Frequency: 2 affected / 234 at risk

Adverse event: Anatomy/Techical Difficulty
Serious: no
Organ System: Surgical and medical procedures
Frequency: 9 affected / 234 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 234 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 234 at risk

Adverse event: Death
Serious: no
Organ System: General disorders
Frequency: 1 affected / 234 at risk

Adverse event: Dysphagia/Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 39 affected / 234 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 234 at risk

Adverse event: Extraskeletal ossification
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 234 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 56 affected / 234 at risk

Adverse event: Malpositioned Implant
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 234 at risk

Adverse event: Neck and/or Arm Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 102 affected / 234 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 124 affected / 234 at risk

Adverse event: Non-Union
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 234 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 99 affected / 234 at risk

Adverse event: Other Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 131 affected / 234 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 234 at risk

Adverse event: Spinal disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 234 at risk

Adverse event: Injury
Serious: no
Organ System: Social circumstances
Frequency: 52 affected / 234 at risk

Adverse event: Upper Extremity Nerve Entrapment
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 234 at risk

Adverse event: Urogenital
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 234 at risk

Adverse event: Wound Issue -- Non-Infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 234 at risk

Adverse event: Anatomy/Technical Difficulty
Serious: yes
Organ System: Surgical and medical procedures
Notes: Anatomy/Technical Difficulty includes Cervical - Study Surgery, Cervical - Non Study Surgery and Non Cervical
Frequency: 1 affected / 105 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Dysphagia/Dysphonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: includes all reported AEs of Dysphagia and other terms consistent with "difficulty swallowing" and all reported AEs of Dysphonia and other terms consistent with "voice change and/or disruption".
Frequency: 2 affected / 105 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 105 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Infection includes Superficial Wound - Cervical, Deep Wound - Cervical, Other Wound - Non Study Surgery, both Systemic and Local
Frequency: 3 affected / 105 at risk

Adverse event: Neck and/or Arm Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Neck and/or Arm Pain includes pain (and related pain terms) specific to neck (cervical spine) and arm pain (and related pain terms) specific to arm (spinal disorders are recorded elsewhere).
Frequency: 6 affected / 105 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Notes: Neurological including Upper Extremity - Sensory, motor, reflex; Lower Extremity - Sensory, motor, reflex; Upper \& Lower Extremity - Sensory, motor, reflex; neck, back, spinal cord disturbance; gait disturbance, non specific and other
Frequency: 5 affected / 105 at risk

Adverse event: Non-union
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-Union includes non-union, cervical fusion failure, pseudoarthrosis, and pending non-unions as reported ; limited to study surgery related events of non-union.
Frequency: 11 affected / 105 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: includes Blood/Lymphatic, Congenital/Genetic, Ear/Labyrinth, Endocrine, Eye, Immune, Metabolism/Nutrition, Musculoskeletal /CT, Benign Neoplasm, Nervous, Psychiatric, Repro, Skin, Vascular , Poisoning, Pregnancy, Social \& surgical/Medical procedures
Frequency: 9 affected / 105 at risk

Adverse event: Other pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Other Pain including Shoulder, Back, Torso, Lower Extremity, Headache, Other
Frequency: 3 affected / 105 at risk

Adverse event: Spinal disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Spinal Disorder including Cervical - Study Surgery, Cervical - Non Study Surgery and Non Cervical
Frequency: 7 affected / 105 at risk

Adverse event: Injury
Serious: yes
Organ System: Social circumstances
Notes: includes falls, motor vehicle accidents, assault, injury, etc. This category includes both cervical and non-cervical AEs of Trauma.
Frequency: 2 affected / 105 at risk

Adverse event: Urogenital
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Wound Issue - Non-infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: including Hematoma, Hematoma Evacuation and CSF Leakage
Frequency: 3 affected / 105 at risk

Adverse event: Anatomy/Techical Difficulty
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 105 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 105 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 105 at risk

Adverse event: Dysphagia/Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 105 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 105 at risk

Adverse event: Extraskeletal ossification
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 105 at risk

Adverse event: Neck and/or Arm Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 63 affected / 105 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 78 affected / 105 at risk

Adverse event: Non-Union
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 105 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 58 affected / 105 at risk

Adverse event: Other Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 64 affected / 105 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 105 at risk

Adverse event: Spinal disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 105 at risk

Adverse event: Injury
Serious: no
Organ System: Social circumstances
Frequency: 20 affected / 105 at risk

Adverse event: Upper Extremity Nerve Entrapment
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 105 at risk

Adverse event: Urogenital
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 105 at risk

Adverse event: Vascular Intraoperative
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 105 at risk

Adverse event: Wound Issue -- Non-Infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 105 at risk