Possible Adverse Effects - Limacorporate SMART SPACE 3D Mode D'emploi

Do not use a sawing blade that is thicker than the indicated thickness of the cutting slot, if present.
Do not use a K-Wire/drill that is larger than the indicated diameter or the hole on the 3D Positioner. The Case
Report lists the K-Wire/drill diameters to be used.
Make sure that the sawing blade follows the cutting surface or slot to obtain a correct osteotomy and to avoid
cutting into the guide's cutting surface or slot.
Since the inner diameters of the K-Wire/drill holes are larger than the diameter of the K-Wire/drill, try to drill
along the centerline of the K-Wire/drill holes to obtain a correct hole and to avoid drilling into the inner wall of
the K-Wire/drill hole.
During drilling irrigate to reduce heat.
Whether applied, drilling and cutting can produce material debris. After this phase, carefully clean the surgical
site and verify the absence of debris.

3.3. POSSIBLE ADVERSE EFFECTS

A commonly adverse effect is the inflammatory response, following the surgical procedure. Introduction of
foreign materials can result in an inflammatory response, hypersensitivity or allergic reaction.
Other adverse effects can be found in the SMR Shoulder System and the SMR TT Hybrid Glenoid System
Instructions For Use. Those adverse effects can occur in shoulder arthroplasty with the abovementioned
implants, which are implanted by means of the Smart SPACE 3D Positioners System.
In case adverse events would occur, it is important that the patient contacts their general practitioner or
orthopedic surgeon for further clinical follow-up.
4. STERILITY
The devices included in the Smart SPACE 3D Positioners System are supplied cleaned and NON-STERILE.
Sterilize the devices using pre-vacuum steam sterilization before use, according to parameters indicated in
this document.
The devices are supplied in double pouches to assure bioburden control. If the packaging is damaged or open,
the device cannot be used, and it must be returned to LimaCorporate.
Before performing sterilization process, the outer package (cardboard box) must be removed. Sterilize the
devices with the double pouch.
LimaCorporate advises to use one of the following pre-vacuum steam sterilization methods (tables 1, 2 and 3):
Sterilization temperature
Sterilization time
Drying time
Table 1 – Method of pre-vacuum steam sterilization
134°C (273.2°F)
3 min
20 min
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