baholzer - B-DYN

Page 3 / 48 All of the possible adverse events associated with spinal surgery with instrumentation are possible. A listing of potential adverse events linked to the medical device includes, not limited to : - Early or late loosening of any or all of the components - Disassembly, bending and/or breakage of any or all of the components (screw breakage) - Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice, fretting, and/or general corrosion), including metallosis, tumor formation and/or autoimmune disease - Pressure on the skin from components parts with inadequate tissue coverage over the implant possibly causing skin penetration, irritation, fibrosis, neurosis, and/or pain - Tissue or nerve damage caused by improper positioning and placement of implants or instruments - Post-operative change in spinal curvature, loss of correction, height, and/or reduction 7-PRECAUTIONS FOR USE The BDyn devices are delivered sterile, sterilized by ethylene oxide for the BDyn spinal shock absorber and by Gamma irradiation for the pedicle screws with plug and the replacement rigid rods. Before any use, inspect the integrity of the packaging and device (including peelable pouches). Do not use in the event of deterioration of the labels and/or the device and/or the packaging. Do not use if the device is out of date. The sterile spinal dynamic posterior stabilization device BDyn is only intended to adult human female or male more than 40 Kg. COUSIN BIOTECH does not offer any guarantee or recommendation as far as the use of a particular type of means of fixation is concerned. The implantation of the BDyn spinal shock absorber has to be carried out only with the dedicated polyaxial pedicle screws BDyn manufactured by the company COUSIN BIOTECH. The eventual substitution of the BDyn spinal shock absorber has to be carried out only with the dedicated replacement rigid rods BDyn manufactured by the company COUSIN BIOTECH. You should never use implants made of stainless steel and titanium alloy in the same construct. A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many extenuating circumstances may compromise the results. This device system is not intended to be the sole means of spinal support. No spinal implant can withstand body loads without the support of bone. In this event, bending, loosening, disassembly and/or breakage of the device(s) will eventually occur. Preoperative and operating procedures, including precise knowledge of suitable surgical techniques, and proper selection of the good reference of the device adapted to the patient and its narrow setting up are important considerations in the successful use of the device by the surgeon. The BDyn device must be implanted only by a qualified surgeon, having knowledge in the use of the product and who has the knowledge of the anatomy, spinal surgery, pedicle screws fixation technique and specific BDyn device surgical technique Postoperative precautions MRI SAFETY: The implants are composed of non ferromagnetic materials and present a geometry non susceptible to generate induced currents. Moreover, as they are fixed to bone/or /tissues, they are unlikely to be mobilised. A priori they can be considered compatible with an MRI scan. Their safety, in particular in terms of heating and migration of implant has been avaluated through bibliographic data by comparison with data available on devices with similar composition, shape and use. This evaluation concluded to a safety use for MRI scan between 1.5 and 3 Tesla. As a precautionary measure, it is recommended to avoid MRI scans within the 48h of the implant placement, and to inform the person in charge of the scan of the recent implant placement, if such examination is essential. It has to be noted that the devices which present a high contrast with the biological environment can generate « artifacts » that has to be taken into account for the perfect execution and interpretation of imaging exams. For this purpose, it has to be recommended to the patient who has this implant to warn as far as possible the concerned health professionals (radiologists and radiology operators) about the presence of this implant before these exams. IMPORTANT: DO NOT REUSE - DO NOT RESTERILIZE In accordance with the labelling of this product, BDyn implants are for single use; they must not in any case be reused or re-sterilised (potential risks include, but are not limited to, loss of sterility of the products, risk of infection, loss of product efficacy, recurrence, etc.) 8-SURGICAL TECHNIQUE The placement of the spinal dynamic posterior stabilization device BDyn begins by the preparation of the pedicles of the vertebrae and by the pedicle aim and the fixation of the pedicle screws. When tapping the vertebrae to prepare the hole before the insertion of the pedicle screw, flexion efforts on the tap are to be avoided. It must stay in the lined-up in order to make as straightest a pre-hole as possible to ensure as secure a screw placement as possible, with a straight guidance way. Thus, when tapping the vertebrae in order to stay in the line-up and to create a straight pre-hole. Viewed in the sagittal plane, the pedicle screws must be as parallel as possible in order to let the biggest available space to place the cylindrical body of BDyn spinal shock absorber and facilitate its insertion between the head of the polyaxial pedicle screws. It is preferable to be sure that the adequate implant, with an appropriate size is used with the instrumentation which suit. A 2 mm space between the top of the cylindrical body of the BDyn spinal shock absorber and the lower part of the screw head must be respected to insure the shock absoption stock necessary for the good working of the BDyn device. For that, the surgeon can use the trial device M50 to check if there is enough space to place the BDyn spinal shock absorber. The mobile piston rod of the BDyn spinal shock absorber must be fixed in the head of the screw concentrically to the cylindrical body. The surgery ends by the final tightening by using the dedicated torque limiting of the plugs on the head of the polyaxial pedicle screws by using systematically the suitable antirotator. It is important to manipulate correctly the implants. The components of the implants to be arched do not have to be against-arched in the opposite direction. In any case they have to be chipped. These operations could effectuate the concentration of internal stresses which could become the place of an eventual failure of the implant. 9-PRESENTATION AND WARNING ABOUT ANCILLARIES - The BDyn ancillaries are Class I medical devices, intended for temporary use and are re-usable. Unlike the BDyn implants, the ancillaries included in the instrument set are furnished non sterile. Before use, the ancillaries must be: - cleaned by the appropriate mode of cleaning - sterilized in an autoclave by moist heat After use, the ancillaries have to be cleaned and decontaminated according to a suitable protocol especially by taking into account the reduction of the risk of transmission of unconventional transmissible agents - UTA. In case of a patient suspected of having Creutzfeld-Jacob Disease (CJD), perform suitable decontamination. In the event of a confirmed case of CJD, incinerate the ancillaries. 10-DECONTAMINATION AND CLEANING OF BDYN ANCILLARIES Decontamination and cleaning are performed under the responsibility of the healthcare centers. The following prescribed methods and materials must be used to reduce the risk of transmission of UTA, (French health ministry - DGS/R13/2011/449 dated 01/12/2011). This step has to take place before the first utilization and immediately after the utilization to avoid adhesion of particles or dry secretion to the instruments The detachable instruments have to be dismantled