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                 SDI Surgical Diamond Instruments – Handling
4.1 Factors which may impair the success of the op- era on
• inadequate bone quality (e.g.„ osteoporosis, previ- ous cruciate ligament opera on. etc.)
• Systemic diseases and metabolic disorders
• Anamnes cindica onsofinfec onorrecurringinci- dents of falling
• Drug addic on. Alcohol or medica on abuse
• Insu cient pa ent compliance 4.2 Possible adverse e ects
In isolated cases, following the opera on, a temporary slight  ssue reac on in the form of a joint e usion may occur, which quickly repairs itself. In very isolated cas- es. Slight bone loss may occure around the implant site (Osteolysis).
4.3 Obliga on to inform pa ent
The surgeon must explain to the pa ent the factors which may impair the success of the opera on and the possible adverse e ects, as described in the sec ons “contraindica ons” and “Possible adverse e ects”, in so far as they are applicable to the pa ent. The sur- geon must also explain to the pa ent the measures which can be taken to reduce possible impairment and adverse e ects.
4.4 Performance of opera on
• The surgeon is responsible for the professional per- formance of the opera on.
• The use of the instrument set requires basic knowl- edge of the instrument set itself as well as knowl- edge of this implanta on/transplanta on technique.
• Donottouchroughsurfaceswithclothsormaterials displaying lint.
• We only recommend the bone Subs tute materials listed in this document for the  lling of osseous de- fects.
• The use and handling of the special instruments must be veri ed at regular intervals prior to intraop- era ve applica on.
REV0116112017EN
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