Study: NCT01925339

Adverse event: Appendix removed
Serious: no
Organ System: Surgical and medical procedures
Notes: One subject had his appendix surgically removed.
Frequency: 1 affected / 20 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: One subject was treated for atrial fibrillation.
Frequency: 1 affected / 20 at risk

Adverse event: Asthma attack
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One subject reported being treated by her primary care physician for asthma-related symptoms.
Frequency: 1 affected / 20 at risk

Adverse event: Dental caries
Serious: no
Organ System: General disorders
Notes: Two subjects reported having to have dental cavity fixed.
Frequency: 1 affected / 20 at risk

Adverse event: Blood disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: One subject reported going to a doctor to be tested for a blood disorder.
Frequency: 1 affected / 20 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Notes: One subject reported being treated for dehydration.
Frequency: 1 affected / 20 at risk

Adverse event: Gastrointestinal problems
Serious: no
Organ System: Gastrointestinal disorders
Notes: One subject reported being treated for diarrhea. One subject reported being treated for diverticulitis.
Frequency: 1 affected / 20 at risk

Adverse event: Tooth sensitivity
Serious: no
Organ System: General disorders
Notes: Two subjects reported having dental sensitivity around non-study teeth.
Frequency: 1 affected / 20 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: General disorders
Notes: One subject had a tooth abscess on a non-study tooth.
Frequency: 1 affected / 20 at risk

Adverse event: Exudate at implant site
Serious: no
Organ System: General disorders
Notes: Exudate (pus) was noted at implant site.
Frequency: 3 affected / 20 at risk

Adverse event: Gum tissue tenderness
Serious: no
Organ System: General disorders
Notes: Two subjects reported having gum tissue tenderness.
Frequency: 2 affected / 20 at risk

Adverse event: Healing abutment
Serious: no
Organ System: General disorders
Notes: Healing abutment screw became loose.
Frequency: 3 affected / 20 at risk

Adverse event: Exposed implant
Serious: no
Organ System: General disorders
Notes: One subject's implant perforated the buccal plate.
Frequency: 1 affected / 20 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Notes: One subject was treated for a kidney stone.
Frequency: 1 affected / 20 at risk

Adverse event: Poison ivy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: One subject reported being treated for poison ivy.
Frequency: 1 affected / 20 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: One subject reported seeing her primary care physician for sports-related shoulder pain.
Frequency: 1 affected / 20 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Immune system disorders
Notes: One subject reported being treated for shingles.
Frequency: 1 affected / 20 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One subject reported being treated for a sinus infection.
Frequency: 1 affected / 20 at risk

Adverse event: Gum tissue inflammation
Serious: no
Organ System: General disorders
Notes: One subject had a lot of gum tissue inflammation at the site of the implant.
Frequency: 1 affected / 20 at risk

Adverse event: Swelling
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: One subject reported being treated for swelling in her hands and feet.
Frequency: 1 affected / 20 at risk

Adverse event: Issues with temporary crown
Serious: no
Organ System: General disorders
Notes: Two subjects had minor issues with their temporary crowns.
Frequency: 2 affected / 20 at risk

Adverse event: Twisted ankle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Two subjects reported twisting their ankles and needing to be seen by their physicians.
Frequency: 1 affected / 20 at risk

Adverse event: Urinary track infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Two subjects reported being treated for urinary track infections.
Frequency: 1 affected / 20 at risk

Adverse event: Issues related to tooth #30
Serious: no
Organ System: General disorders
Notes: One subject had the crown on tooth #30 come off.
Frequency: 1 affected / 20 at risk

Adverse event: Bad taste in mouth
Serious: no
Organ System: General disorders
Notes: Two subjects reported having a bad taste in her mouth.
Frequency: 2 affected / 20 at risk

Adverse event: Bone grafting material at implant site
Serious: no
Organ System: General disorders
Notes: One subject had extra bone grafting particles at implant site.
Frequency: 1 affected / 20 at risk

Adverse event: Dental caries
Serious: no
Organ System: General disorders
Notes: Two subjects reported having to have dental cavity fixed.
Frequency: 1 affected / 20 at risk

Adverse event: Falls
Serious: no
Organ System: General disorders
Notes: Two subjects reported accidentally falling and having to see their primary care physicians.
Frequency: 2 affected / 20 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: One subject reported being treated for a deep vein thrombosis.
Frequency: 1 affected / 20 at risk

Adverse event: Gastrointestinal problems
Serious: no
Organ System: Gastrointestinal disorders
Notes: One subject reported being treated for diarrhea. One subject reported being treated for diverticulitis.
Frequency: 1 affected / 20 at risk

Adverse event: Tooth sensitivity
Serious: no
Organ System: General disorders
Notes: Two subjects reported having dental sensitivity around non-study teeth.
Frequency: 1 affected / 20 at risk

Adverse event: Exudate at implant site
Serious: no
Organ System: General disorders
Notes: Exudate (pus) was noted at implant site.
Frequency: 3 affected / 20 at risk

Adverse event: Ingrowing nail
Serious: no
Organ System: Surgical and medical procedures
Notes: One subject had an ingrown toe nail surgically removed.
Frequency: 1 affected / 20 at risk

Adverse event: Healing abutment
Serious: no
Organ System: General disorders
Notes: Healing abutment screw became loose.
Frequency: 2 affected / 20 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: One subject reported having multiple flu-like symptoms.
Frequency: 1 affected / 20 at risk

Adverse event: Tissue impingement
Serious: no
Organ System: General disorders
Notes: One subject's healing abutment was impinging on the adjacent tissue.
Frequency: 1 affected / 20 at risk

Adverse event: Broken tooth
Serious: no
Organ System: General disorders
Notes: One subject reported having a broken non-study tooth.
Frequency: 1 affected / 20 at risk

Adverse event: Tissue trauma
Serious: no
Organ System: General disorders
Notes: One subject had tissue trauma from eating at the site of the implant.
Frequency: 1 affected / 20 at risk

Adverse event: Twisted ankle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Two subjects reported twisting their ankles and needing to be seen by their physicians.
Frequency: 1 affected / 20 at risk

Adverse event: Urinary track infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Two subjects reported being treated for urinary track infections.
Frequency: 1 affected / 20 at risk