Study: NCT00820235

Adverse event: Hospitalised for gall bladder surgery
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hospitalized for follow-up on chest pains
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hospitalized for surgery of infected appendix
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hospitalized for knee replacement
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hospitalization after heart attack
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: Death caused by heart attack
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hospitalized for treatment of infection after vaccination
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Restoration failure
Serious: no
Organ System: Product Issues
Notes: Fractured/mobile/de-bonded dental crown on the study implant.
Frequency: 6 affected / 48 at risk

Adverse event: Loose abutments
Serious: no
Organ System: Product Issues
Notes: Abutment screws temporarily loose
Frequency: 3 affected / 48 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Notes: Mixed Adverse Events Pain (less the 5% per category). Including: swelling of soft tissue, bone loss around implant, fistula, infection, food impaction in tooth etc., etc.
Frequency: 1 affected / 48 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hospitalized due to fever after mastectomy
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Hospitalized for partial nephrectomy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hospitalized due to menstrual hemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 49 at risk

Adverse event: Study implant failled to osseointegrate
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 49 at risk

Adverse event: Restoration failure
Serious: no
Organ System: Product Issues
Notes: Fractured/mobile/de-bonded dental crown on the study implant.
Frequency: 8 affected / 49 at risk

Adverse event: Loose abutments
Serious: no
Organ System: Product Issues
Notes: Abutment screws temporarily loose
Frequency: 2 affected / 49 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Notes: Mixed Adverse Events Pain (less the 5% per category). Including: swelling of soft tissue, bone loss around implant, fistula, infection, food impaction in tooth etc., etc.
Frequency: 9 affected / 49 at risk

Adverse event: Hospitalized for follow-up on chest pains
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hospitalized for spine fusion surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hospitalized for gastric surgery
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hospitalization after heart attack
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hospitalized due to episode of bi-polar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hospitalized for fractured leg after an accident
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hospitalized due to pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hospitalization due to hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Study implant failled to osseointegrate
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 44 at risk

Adverse event: Study implant temporary mobile
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 44 at risk

Adverse event: Restoration failure
Serious: no
Organ System: Product Issues
Notes: Fractured/mobile/de-bonded dental crown on the study implant.
Frequency: 1 affected / 44 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Notes: Mixed Adverse Events Pain (less the 5% per category). Including: swelling of soft tissue, bone loss around implant, fistula, infection, food impaction in tooth etc., etc.
Frequency: 2 affected / 44 at risk