Study: NCT02551770

Adverse event: Breast Cancer diagnosis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Subject diagnosed with breast cancer. Unrelated to device or procedure
Frequency: 1 affected / 51 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Subject reported sinus infection. Unrelated to device or procedure.
Frequency: 2 affected / 51 at risk

Adverse event: Extensive tooth decay
Serious: no
Organ System: General disorders
Notes: Extensive tooth decay site #31. Unrelated to device or procedure.
Frequency: 1 affected / 51 at risk

Adverse event: Cold/Flu
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cold/Flu. Unrelated to device or procedure.
Frequency: 1 affected / 51 at risk

Adverse event: Mild discomfort when chewing
Serious: no
Organ System: General disorders
Notes: mild discomfort with chewing. Possibly related to procedure.
Frequency: 1 affected / 51 at risk

Adverse event: Retrained bony sequestrum
Serious: no
Organ System: General disorders
Notes: Retained bony sequestrum. Unrelated to device or procedure.
Frequency: 1 affected / 51 at risk

Adverse event: Generalized sensation of burning mouth
Serious: no
Organ System: General disorders
Notes: Generalized sensation of burning mouth. Unrelated to device or procedure.
Frequency: 1 affected / 51 at risk

Adverse event: Itching skin reaction gum
Serious: no
Organ System: General disorders
Notes: Itching skin reaction gum. Possibly related to device or procedure.
Frequency: 1 affected / 51 at risk

Adverse event: Itching skin reaction neck area, external
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Itching skin reaction neck area, external, no pain. Possibly related to device.
Frequency: 1 affected / 51 at risk

Adverse event: Fracture of Veneer #21
Serious: no
Organ System: General disorders
Notes: Fracture of veneer #21. Unrelated to device or procedure.
Frequency: 1 affected / 51 at risk

Adverse event: Haematoma
Serious: no
Organ System: General disorders
Notes: Hematoma right side above tooth # 5 and #6. Approx 2-3 cms big. No pain. Definitely related to procedure.
Frequency: 1 affected / 51 at risk

Adverse event: Tooth fracture #23
Serious: no
Organ System: General disorders
Notes: Tooth Fracture #23. Unrelated to device or procedure.
Frequency: 1 affected / 51 at risk

Adverse event: Apical periodontitis
Serious: no
Organ System: General disorders
Notes: Apical periodontitis. Unrelated to device or procedure.
Frequency: 1 affected / 51 at risk

Adverse event: Abscess on extracted tooth #20
Serious: no
Organ System: General disorders
Notes: Abscess on tooth #20. Not study tooth. Unrelated to device or procedure.
Frequency: 1 affected / 51 at risk

Adverse event: Bleeding and mobility at #24 and 28
Serious: no
Organ System: General disorders
Notes: Bleeding and mobility at teeth #24 and #28. Unrelated to device or procedure.
Frequency: 1 affected / 51 at risk

Adverse event: Loosening of bridge
Serious: no
Organ System: General disorders
Notes: Loosening of bridge. Unrelated to device or procedure.
Frequency: 1 affected / 51 at risk

Adverse event: Sensitivity to cold teeth # 4,5,7 and 9-11
Serious: no
Organ System: General disorders
Notes: Sensitivity to cold teeth # 4,5,7 and 9-11. Possibly related to procedure.
Frequency: 1 affected / 51 at risk

Adverse event: Unclear tooth complaint #5 and #6
Serious: no
Organ System: General disorders
Notes: Unclear tooth complaint #5 and #6. Unrelated to device or procedure.
Frequency: 1 affected / 51 at risk

Adverse event: Restoration prosthetic problem
Serious: no
Organ System: General disorders
Notes: Restoration prosthetic problem. Unrelated to device or procedure.
Frequency: 1 affected / 51 at risk

Adverse event: Hypersensitivity to pain # 22 and 25-28
Serious: no
Organ System: General disorders
Notes: Hypersensitivity to pain #22 and 25-28. Possibly related to procedure.
Frequency: 1 affected / 51 at risk

Adverse event: Sensitivity to warmth and cold # 19,21,22,25,27-29
Serious: no
Organ System: General disorders
Notes: Sensitivity to warmth and cold #19,21,22,25,27-29. Definitely related to procedure.
Frequency: 1 affected / 51 at risk