Unofficially notified investigation – instruments

Product performance data for the last year - instruments - BM86 C

Unofficially notified investigation baseline data

Partner company:

Exact type of instruments concerned:

Number of tools used:

Number of patients:

Feedback date:

Number of instruments successfully used

Number of cases where an adverse reaction/complication occurred

Type of instruments involved in adverse reactions/complications

Distribution of side effects by typecan be expressed as number of units or as a percentage

Thrombosis, embolism:

Excessive bleeding:

Nerve and vessel damage:

Soft tissue damage (swelling, abnormal wound formation):

Allergy or hypersensitivity:

Musculo-skeletal functional impairment

lack of bone healing or inadequate bone healing

Acute anaemia

Septic shock

Device breakage, cracking

Device deformation

Overheating

A usage error related to the use of the device

Other:

Number of device-related adverse events

Device breakage, cracking:

Tool deformation:

Usage error related to the application of the device:

Other:

Average functional satisfaction with the tools1-not at all satisfied, 5-fully satisfied

Were the assets exposed to extreme stress?yesno

Way of extreme stress

Other comments, ideas, observations