prodisc-l total disc replacement...

ProDisc-L Total DiscReplacement. PatientInformation.

Instruments and implants approved by the AO Foundation

Synthes Spine ProDisc-L Total Disc Replacement

Patient Information

Introduction

After reviewing your history and x-rays,and taking into account the results ofother diagnostic studies, your surgeonhas decided that you need spine surgery.You have been provided this patient information brochure to assist you inmaking an informed choice regardingthe treatment of your back pain with the ProDisc-L Total Disc Replacementfrom Synthes Spine.

Your spine is very important, it providesbalance and allows you to move andbend. You would be unable to sit orstand without the support it provides to your body.

The spine is made up of twenty-fourbones, called vertebrae. Each of thesebones has a hole in it, similar to a donut.They are stacked one on top of theother, forming a column.

The spine is divided into four areas. Thebones of your neck are called cervicalvertebrae. The middle section of yourback is the thoracic region. Your lowerback is the lumbar area. The base ofyour spine is made up of the sacrum and coccyx bone, commonly called thetail bone.

Cervical

Thoracic

Lumbar

Sacrum and Coccyx

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The vertebrae are separated by a cush-ioning disc. Passing through the hole of each vertebra is the spinal cord. Thespinal cord contains nerves that carrysignals from your brain to the rest ofyour body. Your spine protects yourspinal cord from injury.

Diagnosis

Your doctor has diagnosed that the painin your lower back is coming from thebottom of the lumbar area and, possibly,the top of the sacrum. You may hear yourdoctor refer to the involved lumbar areasas L3, L4 and L5 and the sacrum as S1.

Normally, the disc sandwiched betweeneach vertebra provides the cushioningspace that keeps the bones separated.Degenerative Disc Disease, or DDD, is acondition that can occur when the discsno longer function normally because ofwear, or from being injured. This cancause pain that limits your ability to per-form daily activities. Surgery for this con-dition may provide relief.

L5

L4

L3

S1


Patient Information

Treatment

You have been diagnosed with Degener-ative Disc Disease and all the treatmentsyou have tried so far have not made youfeel better. Your surgeon believes thatyou may benefit from surgery. The tradi-tional method of treatment has beenspinal fusion. In spinal fusion surgery,the unhealthy disc is removed, the bonesare fixed in position with implants, andbone graft is placed in the area. In mostcases, the bone for the graft is obtainedfrom the patient’s hip bone through aseparate incision. After surgery, bone issupposed to grow between the two ver-tebrae, creating one solid piece of bone.If you have fusion surgery, it may takeyour pain away, but the vertebrae sur-rounding the disc space are immobilized.

You have another option. The ProDisc-L Total Disc Replacement isdesigned to replace your unhealthy disc.

The ProDisc-L Total Disc Replacement is a ball and socket implant consisting oftwo metal endplates and one plastic in-lay. The plastic inlay snap-locks into thelower endplate and provides the ballthat rides in the socket of the upperendplate that is intended to allow mo-tion. There are also fins on the endplatesthat lock them into the vertebral bone.

There are several potential advantagesassociated with ProDisc-L Total Disc

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Replacement over spinal fusion surgery.A United States clinical trial establishedthat patients receiving the ProDisc-L TotalDisc Replacement achieved pain reliefequal to spinal fusion while maintainingsome motion in their spine in many cases.It is believed that maintaining motionmay allow your spine to remain healthierlonger, but this has not been proven.

The ProDisc-L Total Disc Replacementsurgery does not require a bone graft.This means that you may avoid the painand healing time associated with thesecond incision that might be needed if you were to have a fusion procedurewhich required bone to be taken fromyour hip.

Making the Choice

You should discuss the options availableto you with your doctor. Only your doc-tor can decide whether you are a candi-date for receiving the ProDisc-L TotalDisc Replace ment. In order to be a can-didate to receive the ProDisc-L Total DiscReplacement you must meet the follow-ing minimum requirements:

– Must be suffering from DegenerativeDisc Disease (DDD) at only one levelbetween L3 and S1. DDD is defined asa disc that is worn out or has becomeinjured and is causing pain. This deter-mination is made based on history,physical examination and x-rays;


Patient Information

Making the Choice continued

– Should have had at least six months ofconservative treatment without reliefof symptoms (e.g., medications, physi-cal therapy, etc.);

– Vertebrae must be dimensionally largeenough to support the device;

– Must not have an active infection, ei-ther throughout your body or localizedto your spine;

– Must have good bone quality (no osteoporosis or osteopenia);

– Must not be allergic to cobalt,chromium, molybdenum, polyethylene, titanium or tantalum;

– Must be old enough that the bones inyour body are mature and no longergrowing;

– Must not have spinal anatomy thatwould prevent implantation of the de-vice or cause the device to be unstablein your body, as determined by yourdoctor.

Your occupation or activity level, yourweight, the condition of other levels ofyour spine, whether or not you are pregnant, and any allergies you havemay influence whether you should havethe ProDisc-L Total Disc Replacement sur-gery. If any of these factors apply to youor if you think that you have any specialhealth issues, please make sure to informyour doctor.

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Surgery

During disc replacement surgery, you will be under general anesthesia. Eventhough you are having lower back sur-gery, your surgery will be performedthrough an incision in your abdomen.You will be lying on your back. Duringyour surgery, the surgeon will removethe unhealthy disc and replace it withthe ProDisc-L implant.

After Surgery

Surgery with the ProDisc-L Total Disc Replacement is considered major sur-gery. As with any major surgery, youshould expect some discomfort as wellas a period of rehabilitation. Your doctormay prescribe medicines to help youmanage any pain or nausea you may experience. You should expect to stay inthe hospital for at least a few days. Theaverage hospital stay for disc replace-ment surgery patients in the clinicalstudy for the ProDisc-L was about 3.5days (range: 1.0–8.0 days). Prior to go-ing home, you will be taught how tocare for your incision, and you and your doctor should discuss a plan to graduallybring you back to normal activity. It isvery important that you follow your surgeon’s instructions. Try not to do toomuch, too soon.


Patient Information

After Surgery continued

Contact your doctor immediately if you:– Have a fever

– Notice fluid draining from your incision

– Have trouble swallowing or breathing

– Have trouble urinating

– Have new or increased back or legpain, numbness, or weakness

Caution: Please be sure to tell your doctor that you had surgery with theProDisc-L before you have a magneticresonance imaging (MRI) taken. Themetal in the ProDisc-L can affect thequality of the images taken.

Complications

As with any surgery, there are some pos-sible complications that can occur whenyou have total disc replacement surgerywith the ProDisc-L implant. Complicationscan occur singly or in combination andmay include:– Allergic reaction to the implant

materials

– Bladder problems

– Bleeding, which may require a bloodtransfusion

– Blood clot (emboli) in the bloodstream or lungs

– Death

– Difficulty with bowel movement orother problems with your bowels

Warning: Overloading of the spine byengaging in extreme activities (i.e., heavyweight-lifting) may result in failure of theimplant.

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– Failure of implant/procedure to improveyour symptoms and/or ability to function

– Failure of incision to heal properly orother incision problems

– Fracture of the vertebrae

– Fusion

– Implant failure (e.g., implants thatbend, break, loosen or move)

– Impotence or retrograde ejaculation

– Infection

– Injury to internal structures such asyour kidney, ureter, bowel, blood vessels, or lymphatic vessels

– Need for additional surgery which couldinclude removal of the ProDisc-L implant

– Pain or discomfort

– Paralysis

– Phlebitis (swelling of veins)

– Pneumonia

– Problems with your blood vesselsother than bleeding

– Seizures

– Side effects from anesthesia

– Spinal cord or nerve damage

– Spinal fluid leakage

– Spinal instability

– Tears of the dura (a layer of tissue covering the spinal cord)

– Wear debris (load-bearing implantsthat allow motion have been shown topotentially generate wear debris overtime. Early and/or long-term effects ofwear debris in the human spine arenot yet known)


Patient Information

Information about the U.S. ClinicalStudy of the ProDisc-L Total Disc Replacement

The U.S. clinical study of the ProDisc-LTotal Disc Replacement demonstratedthat patients who received the ProDisc-Limplant had improvement in function,which was the same as patients who hadfusion surgery when evaluated two yearsafter surgery. The rates of complicationswere approximately the same betweenthe two groups. Ask your surgeon formore details about the clinical study andits results.

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Conclusion

You have been diagnosed with Degenerative Disc Disease and your surgeon believes that you need surgeryto make you feel better. You shouldcarefully consider whether to have spinesurgery. If you decide to have spine sur-gery, you should discuss all the availableoptions with your surgeon. The ProDisc-L Total Disc Replacementhas been determined to be safe and effective in the treatment of Degenera-tive Disc Disease at one level in thelower back. Synthes Spine has providedthis brochure in an effort to inform youabout your treatment options. If youwould like additional information orhave more questions about artificial discsurgery, please contact your doctor.

Call Synthes Spine at 1-800-895-7764 orvisit our website atwww.synthesprodisc.com

This patient information brochure is nota replacement for professional medicaladvice. Only your surgeon is qualified todiagnose and treat your back pain.

Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19380Telephone: (610) 719-5000To order: (800) 523-0322Fax: (610) 251-9056

© 2006 Synthes, Inc. or its affiliates. All rights reserved. Printed in U.S.A. 4/08 J6356-CProDisc and Synthes are trademarks of Synthes, Inc. or its affiliates.

www.synthes.comwww.synthesprodisc.com

You may wish to record important information regarding your ProDisc-L Total Disc Replacement.

Please ask your surgeon for thisinformation.

Lot No.

Superior Endplate

Inlay

Inferior Endplate

Limited Warranty and Disclaimer:Synthes Spine products are sold with alimited warranty to the original purchaseragainst defects in workman ship andmaterials. Any other express or impliedwarranties, including warranties ofmerchantability or fitness, are herebydisclaimed.

Warning: In the U.S.A., this product haslabeling limitations. See package insertfor complete information.

Caution: Federal (USA) law restricts thisdevice to sale by or on the order of aphysician (or properly licensed practi-tioner) who has appropriate training experience.

Synthes (Canada) Ltd.2566 Meadowpine BoulevardMississauga, Ontario L5N 6P9Telephone: (905) 567-0440To order: (800) 668-1119Fax: (905) 567-3185

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