OMNIPORE SURGICAL IMPLANT. Porous High-Density Polyethylene Implants For Reconstructive and Aesthetic Surgery

Transcription

1 OMNIPORE SURGICAL IMPLANT Porous High-Desity Polyethylee Implats For Recostructive ad Aesthetic Surgery

2 OMNIPORE Surgical Implat Hadlig Techiques Implat Preparatio OMNIPORE Surgical Implats are sold sterile ad should ever be re-sterilized. Prior to hadlig the implats, operatig room persoel should put o a clea pair of powder free gloves. Keep the implat i its protective packagig util time of implatatio. Upo opeig the ier pouch, the implat should be placed i a solutio of clea sterile physiologic salie ad atibiotics of the surgeo s preferece. Strict adherece to the priciples of aseptic techique should be followed with these implats. Proper surgical procedures ad techiques are ecessarily the resposibility of the medical professioal. Cuttig OMNIPORE Surgical Implats are easily cut with a variety of surgical istrumets. The uique physical properties of the OMNIPORE Surgical Implats allows for cuttig ad trimmig the implat while maitaiig the itercoectivity ad the structure of the pores. CAUTION: Do ot place or carve the implat o surgical drapes, surgical clothig or ay other surface which may cotamiate the implat with lit ad other particulate matter. A sterile carvig block ca be used as a work surface for carvig OMNIPORE Surgical Implats. Cotourig & Shapig Allow the implat to soak several miutes i a hot (above 90 C) salie bath. The hot salie bath will relax the memory of the implat, eablig modificatio of the shape. Test the implat for flexibility. Soak loger if the implat does ot bed easily. Hold the implat i the desired shape ad allow it to cool. A cold sterile salie bath ca accelerate the coolig process. Repeat these steps if further modificatio is required. Implat Stabilizatio Whe fixatio of the implat is desired, stabilizatio may be accomplished with suture, k-wire or rigid fixatio screws. I the case of screw fixatio, tighteig the screw will compress the implat to the boe ad will eable the surgeo to sik the screw head flush with the implat surface. Oe advatage of stabilizig the implat is the ability to delicately shape ad feather the edges of the implat i-situ after fixatio. Care should be take to remove all carved debris from the surgical site. Surgical Revisios The porous ature of OMNIPORE Surgical Implats allows for soft tissue igrowth ad vascularizatio of the implat. I patiets that may require later surgical revisio, the surgeo should be aware of this vascular ad soft tissue igrowth. I the evet revisio or removal of the implat is required after igrowth has occurred, the surroudig soft tissue may be raised with a surgical istrumet ad the implat dissected out with a scalpel or surgical scissors. OMNIPORE Surgical Implats are provided sterile ad should ever be re-sterilized. Explated OMNIPORE Surgical Implats should be disposed of i a proper biohazard cotaier. Cosult the product iformatio sheet eclosed with each implat for additioal iformatio, idicatios, cotraidicatios ad precautios. 2

3 OMNIPORE Surgical Implats OMNIPORE implats are maufactured from a liear form of high-desity polyethylee. Polyethylee has a log history of use i surgical implats. OMNIPORE Surgical Implats allow for tissue igrowth because of its itercoectig ope pore structure. The firm ature of the material allows carvig with a sharp istrumet without collapsig the pore structure. OMNIPORE Surgical Implats i blocks, sheets ad preformed aatomical shapes are iteded for augmetatio ad restoratio of the craiomaxillofacial skeleto. The porosity of OMNIPORE Surgical Implats is maitaied large, with average pore sizes greater tha 100 micros ad pore volume i the 50% rage (measured by Mercury Itrusio Porosimitry). Aimal data has demostrated that the OMNIPORE Surgical Implats permit tissue igrowth. The cliical sigificace of tissue igrowth may vary with the applicatio ad implat site. I Vitro ad I Vivo biocompatibility studies have show OMNIPORE Surgical Implats to be free from ay observable systemic or cytotoxic effects. The success of ay implat is depedet upo careful hadlig ad good surgical techique. Porous materials are particularly susceptible to cotamiatio either by micro-orgaisms or foreig material. I order to reduce the chace of cotamiatio by preoperative hadlig, OMNIPORE Surgical Implats are provided sterile i a variety of shapes ad sizes. OMNIPORE Surgical Implats should remai i the protective pouch util the implat site has bee prepared. Select from a array of aatomical shapes, sheets/blocks ad spheres icludig: Preformed shapes for chi, malar, rim, midface ad madibular augmetatio Recostructive shapes for traumatic defects ad Microtic ears Sheets, wedges ad blocks for orbital floor ad wall repair Spheres for eucleatio ad evisceratio procedures A referece list of articles/presetatios ad publicatios o high-desity polyethylee craiofacial implats ad porous polyethylee is available upo request from Matrix Surgical USA. Complete product labelig is icluded i the package isert provided with each OMNIPORE Surgical Implat. The surgeo should adequately review this iformatio before usig the product. The itet of this brochure is to provide the surgeo with illustratios ad dimesios of the may shapes of OMNIPORE Surgical Implats ad acillary surgical products. Implats ca be tailored to accommodate the idividual eed of the patiet. Surgeos should utilize proper surgical techiques for which they were traied ad their cliical experiece to determie appropriate surgical procedures. Successful implatatios are techique sesitive. Soud surgical judgmet should be used i the selectio/shapig ad implatatio of OMNIPORE Surgical Implats. 3

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8 Terms ad Coditios To Order: All implats are shipped for two-day busiess delivery withi the U.S. at o additioal cost. Delivery times may vary accordig to freight delivery schedules. Delivery by ay other service or carrier specified by the customer will be at the customer s expese. Curret Price List pricig shall apply o ivoiced product sales. Customized implats ad surgical models are available upo request; order details, desig requiremets ad lead times may be requested from Customer Care at Retur Goods Authorizatio (RGA): Prior authorizatio ad a Retur Goods Authorizatio (RGA) must be obtaied from Matrix Surgical USA. Call Customer Care at to request a RGA. Freight charges for merchadise retured are the resposibility of the customer. Matrix Surgical USA allows the purchase of back-up implat products for surgery. Back-up implat products will be ivoiced per the curret price list. Requests for retur ad credit for back-up OMNIPORE Implat products less tha $2500 must be made withi 60 days from date of ivoice without pealty or restockig fee, provided the implats remai i the origial uopeed package. Retured product must be adequately packaged to prevet damage durig the retur shipmet. A 20% restockig charge may apply to returs greater tha $2500 ad must be retured withi 60 days of date of ivoice. Credit ad/or refud may NOT be issued for the followig returs: Merchadise retured by other tha origial purchaser. Merchadise sold o a o-returable basis, i.e. customized implats, shelf-pack quatities ad o-implatable devices. Merchadise that has bee opeed, water damaged, crushed or otherwise damaged. Merchadise ot retured i sellable coditio. No returs are allowed after 60 days from date of ivoice. Ay merchadise retured other tha i accordace with the above policies shall become the property of Matrix Surgical USA ad will be dispositioed i a appropriate maer. The decisio of Matrix Surgical USA with respect to the coditio of the retured merchadise shall be fial. * All Iteratioal Distributors should refer to their idividual distributio agreemet for specific terms ad coditios. 14

9 About Matrix Surgical USA Matrix Surgical USA was fouded i 2012 as a privately held compay based i Atlata, Georgia, USA. The compay s core maagemet team has deep domai expertise i the medical device idustry ad extesive experiece with the desig, developmet, productio, marketig ad global distributio of Porous High-Desity Polyethylee Craiofacial Implats. Matrix Surgical USA s flagship product is OMNIPORE Surgical Implats, a biocompatible form of porous High-Desity Polyethylee. The compay offers more tha 80 uique SKUs of various aatomical cofiguratios ad dimesios for recostructio or augmetatio of the craiomaxillofacial skeleto. Our products are available to healthcare providers i the Uited States ad through a global etwork of stockig distributors i more tha 35 coutries aroud the world. The fouders created Matrix Surgical USA for oe special reaso: to be a specialty, iche-focused compay that works i close collaboratio with surgeos from all over the world to develop uique products that offer solutios to some of the most challegig cliical problems they face day i ad day out. Our log history of success servig these cliet surgeos makes us a uiquely qualified parter ad a fast growig compay to watch. Our Missio ad Core Values Matrix Surgical USA was created with the followig core values i mid: To desig, develop ad itroduce state-of-the-art products for recostructive ad aesthetic surgery that exceed customer expectatios ad recogized idustry stadards for quality ad performace ad the requiremets of regulatory bodies from aroud the world. To recogize that our products play a importat role i the healthcare practitioer s (HCP) ability to treat acquired (traumatic) or cogeital diseases; hece, we are midful of our resposibility to support HCPs i the proper selectio ad use of our products to help them achieve the best possible outcome for their patiets. We kow that everythig we accomplish rests o the skills, itegrity, commitmet ad dedicatio of our employees. We offer challegig ad rewardig employmet for our team members ad set high expectatios for performace. Matrix Surgical USA is committed to beig a well-maaged, results-orieted, iovatio-drive orgaizatio whose team members have a passio for progress ad a commitmet to excellece. We costatly strive to be better parters with our customers ad to be more coected, more forward-lookig ad more customer-focused tha our competitors. We strive to be good corporate citizes by actively servig the best iterests of the commuities where we live ad work as well as providig support to humaitaria orgaizatios egaged i deliverig vital health care services aroud the world. 15

10 OMNIPORE Surgical Implats ad Ocular Coformers are provided sterile by Matrix Surgical USA. DO NOT USE ay implat or coformer if the package is ope, damaged or wet. All STERILE items are cosidered sigle use ad caot be re-sterilized. Surgeos should cosult the package isert for istructios o the proper use ad precautios for ay OMNIPORE Surgical Implats or Ocular Coformers prior to use. For additioal iformatio worldwide, please cotact your local OMNIPORE Surgical Implats Distributor; i the U.S., please cotact Matrix Surgical USA directly usig the iformatio below. Distributors should cosult their distributor agreemets for ay claims. All products maufactured ad distributed by Matrix Surgical USA are latex free. Matrix Surgical USA 4025 Welcome All Road, Suite 120 Atlata, Georgia U.S.A. T F ifo@matrixsurgicalusa.com CE Certifi cate Number US12/82636 ISO Certifi cate Number US12/82605 Copyright All rights reserved. The Matrix Surgical USA service mark is owed by or used uder the licese ad authority of Matrix Surgical Holdigs, LLC. OMNIPORE is a registered trademark ad 3S, BENDBLOCK, SBI ad Desig Y are trademarks of Matrix Surgical Holdigs, LLC. IRM2003 ECO E