Unofficially notified investigation – abutments and prosthetics

Unofficially reported inspection – Abutments (F-86-B)

Product performance data for the past year – Abutments (F-86-B). In the absence of exact figures, an estimated value can be provided (if the question is not relevant, please leave it blank).

Unofficially reported test data

Partner company:

Exact type of devices concerned:

Number of devices used:

Number of patients:

Feedback date:

Number of successfully used devices

Number of cases where an adverse reaction/complication occurred

Number of devices lost or removed

Causes of losses and removals:

Distribution of side effects by type

Thrombosis, embolism:

Excessive bleeding:

Nerve and vessel damage:

Soft tissue damage (swelling, abnormal wound formation):

Allergy or hypersensitivity:

Other:

Unofficially reported inspection – Abutments (F-86-B)

Unofficially reported test data

Distribution of side effects by type

Device incident count

BIONIKA Assistant