SANTIS Pedicle Screw System Please read carefully INSTRUCTIONS FOR USE

Transcription

1 SANTIS Pedicle Screw System Please read carefully INSTRUCTIONS FOR USE Package Insert Santis Pedicle Screw System IMPORTANT NOTE The users acknwledge that they have read and agreed n the cnditins in this insert, which are cnsidered t be cntractual. CAUTION Federal Law restricts the device t be sld by, r n the rder f a Physician. BASIC STRUCTURE The Santis Pedicle Screw System is cmprised f: Rds, Pedicle Screw Assemblies fr pen and minimally invasive prcedures, and Crss Cnnectr Assemblies. Varius sizes f these implants are available s that adaptatins can be utilized t take int accunt the unique pathlgy and anatmy f individual patients. MATERIAL Cmpnents are made f Ti6Al4V ELI, a titanium based ally, which cmplies with ASTM F136. The Cbalt- Chrme rds are made frm wrught C- Cr- M ally, which cmplies with AS TM F1537. INDICATION FOR USE The Santis Pedicle Screw System is intended fr immbilizatin and stabilizatin f the spine. The Santis Pedicle Screw System is indicated fr psterir, nncervical pedicle fixatin as an adjunct t fusin in skeletally mature patients using autgraft and/r allgraft fr the fllwing indicatins: degenerative disc disease (DDD) (defined as back pain f discgenic rigin with degeneratin f the disc cnfirmed by histry and radigraphic studies); spndyllisthesis; trauma (i.e., fracture r dislcatin); spinal stensis; curvatures (i.e., sclisis, kyphsis, and/r lrdsis); tumr; pseudarthrsis; and failed previus fusin. PRECAUTION: The implantatin f the Santis Pedicle Screw System shuld be perfrmed nly by experienced spinal surgens with specific training in the use f this pedicle screw system; because this is a technically demanding prcedure presenting a risk f serius injury t the patient. LEVEL OF FIXATION Levels f fixatin are fr the Thracic, Lumbar, and Sacral spine. GENERAL CONDITIONS OF USE The implants must be implanted nly by surgens having undergne the necessary training in spinal surgery. Their use in implantatin must be decided upn in accrdance with the surgical and medical indicatins, the ptential risks, and limitatins related t this type f surgery; the cntraindicatins, side effects, and precautins defined, and in the knwledge f the nature and metallic, metallurgic and bilgical characteristics f the implants. Detailed surgical technique manuals are made available by Lanterna GmbH and supplied thrugh sales representatives. It is recmmended that an extensive review f the surgical technique manual is dne befre attempting surgery. Under n circumstances may the implants be re-used; althugh the device may appear intact n remval, internal mdificatins due t the stresses and strains placed n it, r small defect may exist which may lead t failure f the implant. WARNING: "Warning: The safety and effectiveness f pedicle screw spinal systems have been established nly fr spinal cnditins with significant mechanical instability r defrmity requiring fusin with instrumentatin. These cnditins are significant mechanical instability r defrmity f the thracic, lumbar, and sacral spine secndary t severe spndyllisthesis (grades 3 and 4) f the L5-S1 vertebra, degenerative spndyllisthesis with bjective evidence f neurlgical impairment, fracture, dislcatin, sclisis, kyphsis, spinal tumr, and failed previus fusin (pseudarthrsis). The safety and effectiveness f these devices fr any ther cnditins are unknwn." Benefits f spinal fusin utilizing any pedicle screw fixatin system has nt been adequately established in patients with an unstable spine;

2 There are ptential risks assciated with the use f this system. These risks, if realized, may require additinal surgery; risks include but are nt limited t: device cmpnent fracture, lse f fixatin, nnunin, fracture f the vertebra, neurlgical injury, and vascular r visceral injury; Discard all damaged r mishandled implants; Never reuse an implant; even if it appears t be undamaged; Internal fixatin devices cannt withstand activity and lad levels equal t thse placed n nrmal healthy bne. Until maturatin f the fusin mass is cnfirmed, d nt subject this device t the stresses f full weight bearing activities, r implant failure may result; Cnturing f r bending f a screw, hk, and/r rd may reduce its fatigue strength and cause failure under lad. If a spinal screw r hk is bent r therwise damaged during insertin r adjustment, they must nt be implanted and must be replaced. Rds shuld nly be cntured with the prper cnturing instrument. Incrrectly cnturing rd, r rds that have been repeatedly r excessively cntured must nt be implanted; Mixing Metals; never mix titanium ally r cbalt chrme with any stainless steel material. The Santis Pedicle Screw System shuld nt be used in cnjunctin with cmpnents frm any ther manufacturer s spinal system. Any decisin, by a surgen, t remve the internal fixatin device shuld take int cnsideratin such factrs as the risk t the patient by underging an additinal surgery prcedure as well as the difficulty f implant remval; Implant remval shuld be fllwed by adequate pstperative management t avid fracture. The Santis Pedicle Screw System has nt been evaluated fr safety and cmpatibility in the MR envirnment nr tested fr heating r migratin in the MR envirnment. CONTRA-INDICATIONS Any active r suspected latent infectin in r abut the spine; Any mental r neurmuscular disrder which wuld create an unacceptable risk f fixatin failure r cmplicatin in pst-perative care; Bne stck cmprmised by disease, infectin, r prir implantatin which cannt prvide adequate supprt, and/r fixatin t the device; Obesity; an verweight r bese patient can prduce lads n the device that exceed maximum lad design specificatin; Open wunds; Metal sensitivity, dcumented r suspected; Bne resrptin, stepenia and/r steprsis; Patients having inadequate tissue cverage ver the perative site; Pregnancy; Excessive lcal inflammatin; Other medical r surgical cnditins which wuld preclude the ptential benefit r spinal implant surgery; such as the presence f tumrs, cngenital abnrmalities, elevatin f sedimentatin rate unexplained by ther diseases, elevatin f white bld cunt (WBC), r marked left shift in the WBC differential cunt; PRECAUTIONS Based n the fatigue testing results; the physician/surgen shuld cnsider the level f implantatin, patient weight, patient activity level, r patients cnditin, etc. which may have an impact n the perfrmance f the system; Patients wh smke have been shwn t have an increased incidence f nn-unins. Such patients shuld be advised f this fact and warned f the ptential cnsequences; If the patient is invlved in an ccupatin r activity which applies inrdinate stress upn the implant (e.g., substantial walking, running, lifting r muscle strain) resultant frces can cause failure f the device; In sme cases, prgressin f degenerative disease may be s advanced at the time f implantatin; the disease may substantially decrease the expected useful life f the appliance. In such cases, rthpedic devices may be cnsidered nly as delaying technique r t prvide temprary relief; Befre clinical use, the surgen shuld thrughly understand all aspects f the surgical prcedure and the limitatins f the spinal fixatin device. Spinal fixatin systems require detailed knwledge f spinal surgery. This device is recmmended fr use nly by surgens familiar with preperative and surgical techniques, cautins, and ptential risks assciated with such spinal surgery. Knwledge f surgical techniques, prper reductin, selectin and placement n implants, and pre and pst-perative patient management are cnsideratins essential t a successful surgical utcme; The patient shuld be infrmed in detail abut the limitatins f the implants, including, but nt limited t, the impact f excessive lading thrugh patient weight r activity, and be taught t gvern their activities accrdingly. The patient shuld understand that a metallic implant is nt as strng as nrmal healthy bne and may bend, lsen, r fracture if excessive demands are placed n it. An active, debilitated, r demented patient wh cannt prperly use weight supprting devices may be particularly at risk during pstperative rehabilitatin; Apprpriate selectin, placement and fixatin f the spinal system cmpnents are critical factrs which affect implants service life.

3 As in the case f all prsthetic implants, the durability f these cmpnents is affected by numerus bilgic, bimechanics and ther extrinsic factrs, which limit their service life. Accrdingly, strict adherence t the indicatin, cntra-indicatins, precautins, and warnings fr this prduct is essential t ptentially maximize service life. (Nte: While prper implant selectin can minimize risk, the size and shape f human bne presents limitatins n the size shape, and strength f the implant.); Care must be taken t prtect the cmpnents frm being marred, nicked, r ntched as a result f cntact with metal r abrasive bject. Alteratins will prduce defects in surfaces finish and internal stresses which may becme the fcal pint fr eventual breakage f the implant. SIDE-EFFECTS Late bne grafting r n visible fusin mass and pseudarthrsis; Neurlgical cmplicatin, paralysis, sft tissue lesins, and/r migratin f the implant; Pedicle failure while preparing and inserting the pedicle screws; Superficial r deep-set infectin and inflammatry phenmena; Allergic reactin t the Ti6AL4V ELI ally r cbalt chrme; Reductin in bne density due t different distributin f mechanical stresses; Pain and/r abnrmal sensatins due t hardware bulkiness; Neurlgical and spinal dura mater lesins frm surgical trauma; Bursitis; Presence f micr-particles arund the implants; Grwth f the fused vertebra is altered; Partial lss f the degree f crrectin achieved during surgery; Mdificatin f spinal curvature and stiffness f the vertebral clumn. Death The abve list f side-effects is nt exhaustive. These side-effects can smetimes necessitate further surgical treatments. PACKAGING, LABELING AND STORAGE The implants are prvided in bth STERILE and NON STERILE frmats. NON STERILE implants must be cleaned and sterilized befre use: (see belw) The instruments are supplied NON-STERILE. They must be cleaned and sterilized befre use; (see belw) In the case f STERILE implants, the packages must be intact at the time f receipt. All legal infrmatin required fr this type f implant is given n the label and insert f each package; Use care in handling and strage f implants cmpnent. Cutting, sharply bending, r scratching the surface f the implants can significantly reduce the strength and fatigue resistance f the implant cmpnents. CLEANING AND DISINFECTING PROCEDURES All reusable instruments shuld be cleaned and disinfected between uses. Fllw the directins belw t prperly clean and disinfect reusable instruments prir t sterilizatin. Disassembly Where pssible, disassemble all instruments prir t cleaning, disinfectin and sterilizatin. Clean instruments immediately after use t prevent tissue r bdily fluids frm drying n the instruments. Decntaminatin Saturate the entire surface with full strength disinfectant/cleaner and allw it t remain in cntact fr 5 minutes. D nt use high acidic (ph <4) r high alkaline (ph >10) prducts. Cleaning Instructins Pre-Cleaning Washing Rinsing Inspectin Drying Remve grss cntaminants by immersing devices in a neutral ph enzymatic cleaner. Rinse under warm, running, ptable tap water fr tw(2) minutes Scrub with an apprpriate sft-bristle brush until clean. Thrughly clean the instruments. Wash in an ultrasnic cleaning bath filled with neutral enzymatic detergent slutin (e.g. Miltex EZ-Zyme) prepared accrding t the manufacturer s instructins Ultrasnicate fr 10 minutes r per manufacturer s instructins Disassemble the Extensin Twer as described belw. Rinse under warm, running, ptable tap water fr tw(2) minutes. Visually inspect the instruments t cnfirm there is n visual cntaminatin. If this end pint cannt be met. Dispse f the instrument. Dry devices using an absrbant, nn-shedding clth r industrial ht dryer, r place int a drying cabinet until all misture is remved.

4 Preparatin and Assembly Assemble all instruments that were previusly disassembled. Perfrm a visual and functinal inspectin f all instruments t verify that they are in wrking rder. Replace any reusable instruments that are cracked r damaged r d nt functin. Return the instruments t the instrument trays fr sterilizatin. STERILIZATION PROCEDURES The instruments are supplied NON-STERILE Implants are prvided in bth STERILE and NON STERILE frmats. In the case f NON STERILE implants and all instruments, please fllw these instructins ANSI/AAMI ST79 guidelines fr in-hspital sterilizatin shuld be fllwed fr all implants and instruments. Implants and instruments shuld be sterilized in the sterilizatin case prvided. Sterilizatin cases shuld be wrapped with tw layers f FDA-Cleared wrap, with a surgical twel placed between the bttm f the tray and the wraps. Using a prperly functining and calibrated steam sterilizer, the fllwing parameters may be used fr effective sterilizatin: Pre-Vacuum Steam Sterilizatin 132 C (270 F) Sterilizatin Temperature 4 Minute Sterilizatin Time 40 t 50 Minute Dry Time USEFUL LIFE OF INSTRUMENTS Rutinely inspect devices fr wear and tear. If evidence f wear such as crrsin, pitting, r disclratin is bserved, dispse f the instrument and btain a new instrument frm the manufacturer. If any cutting instruments becme dull and d nt functin prperly, btain a new instrument frm the manufacturer. Disassembly, assembly and Cleaning Instructins SANTIS Screw Extensin Twer- Article # MIS 7902 Quick Reference Guide LANTERNA MEDICAL TECHNOLOGIES RECOMMENDS THE FOLLOWING DISASSEMBLY, ASSEMBLY AND CLEANING SEQUENCE: 1. After use r surgery, turn the cllar in a clckwise directin while applying gentle upward pressure n the internal cmpnent. 2. Remve the internal cmpnent by pulling it ut f the twer. Clean bth parts thrughly. (Refer t Cleaning and Disinfecting Prcedures). 3. After cleaning, Insert the inner sleeve int the tp f the TOWER and align the tw prngs with the internal tracks.

5 4. Insert DILATOR 2 frm the ppsite end f the TOWER. This will prperly set the prngs int the tracks f the TOWER. Advance the inner sleeve until it is fully seated in the TOWER. 5. Turn the cllar cunter clckwise t prperly secure the inner sleeve with the TOWER. GUARANTEE The guarantee is nly applicable if the device is used in accrdance with nrmal cnditins as defined in this instructin insert and in cnfrmity with the recmmended surgical technique. The surgical technique may be btained by cntacting Lanterna at the address belw. Manufacturer: Lanterna Medical Technlgies Rrschacherstrasse 292 St. Gallen, Switzerland, CH (Fax) inf@lanternamedtech.cm