ANTERIOR INSTRUMENTATION · Figure 7b Surgical Technique STEP 3. Outer Sleeve Placement The Double...

ANTERIOR INSTRUMENTATIONSurgical Technique

Table of Contents

Table of Contents

page 2 Advantages

page 3 Instruments

page 4–5 Preoperative Templating

page 6–9 Intraoperative Sizing, Alignment and Templating

a. Block Discectomy Method (Complete Disc Excision Method)

b. Trephining Method (Annulotomy Method)

page 10 Vertebral Distraction and Annular Tensioning

page 11–12 Outer Sleeve Placement

a. Double Barrel Technique

b. Single Barrel Technique

page 13–14 Vertebral Reaming

page 15 Vertebral Tapping

page 16–18 Threaded Construct Placement

page 19 Closure and Postoperative Care

page 20 Product Ordering Information

2

Advantages of the anterior approach instrumentation for placing threaded cylindrical constructs include:

• Color-coded instruments and cases that allow for size-specifi c construct placement (16mm, 18mm, 20mm sizes).

• Sequential distraction process for optimal disc space distraction and height restoration prior to endplate preparation.

• Centering devices for bilateral construct placement that may be used with block discectomy techniques or trephining (partial discectomy) method.

• Sleek, trim double barrel design facilitates easier bilateral placement of constructs.

• Easy-to-use adjustable depth stops allow accurate, controlled passage of instruments.

• Versatile instrumentation allows placement of various construct designs.

• Integrated system design allows for stable, accurate placement of the construct and facilitates a consistent, reproducible operation.

Advantages

3

Instruments

Anterior Approach

Instruments

Template

Adjustable Depth Stop

Threaded Construct Inserter

Quick Disconnect T-handle



T-handle Trephines


Distractor

Centering Pin Shaft

Centering Pin

Threaded Construct Adjustable Reamer

Double Barrel Outer Sleeve Distractor

Single Barrel Outer Sleeve

Distractor

Threaded Cortical Dowel Adjustable Tap

Preoperative Templating

Note: Preoperatively, the surgeon must determine which intervertebral level(s) to operate on. This may be done using a variety of diagnostic techniques, such as radiographs, MRI, discography, patient history and physical examination.

Once the appropriate spinal level has been identified, the proper size construct must be selected. Templates are available to facilitate proper construct selection from plain radiographs, CT or MRI scans. These Templates are available in appropriate reduction or magnification ratios for radiographs and CT or MRI scans. To determine the magnification of a CT or MRI scan, match the scale on the Template with the scale on the CT or MRI scan. Example Templates are shown below.

These Templates also allow the surgeon to measure disc spaces and predistraction requirements. In using the Templates, the physician should ensure that the constructs remain within the lateral borders of the intervertebral disc space, while also penetrating into the vertebral bodies cephalad and caudal to the disc.

4

THREADED CONSTRUCT INSTRUMENTATION TEMPLATE

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MRI - CT SCALES FOR AXIAL CONFIRMATION

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Distract to 6mm minimum8mm maximum

LIT.TC.XRT99




Sample Template

Surgical Technique

STEP 1

5

Preoperative Templating

Intraoperatively, the patient is placed on the operating table in a supine position. The spine may be extended slightly at the surgeon’s discretion. General anesthesia with endotracheal intubation is administered.

Either a transperitoneal or an anterior retroperitoneal approach is suitable. The amount of great vessel release and retraction should be limited to that required for insertion of the instruments and constructs. Ligation of segmental vessels is not usually required. At L5-S1, the middle sacral artery is typically ligated and divided. Care should be taken at L5-S1 to only use blunt dissection to minimize injury to the presacral neural plexus.

Note: The following procedure discusses both a Double Barrel Outer Sleeve and a Single Barrel Outer Sleeve method of placement. The Single Sleeve may be used to place either one or two constructs. Please note that dual constructs are the preferred surgical technique and that a single construct should only be used in cases where neurovascular structures cannot be safely mobilized.

A standard block discectomy is recommended. This will provide space for insertion of the Distractors, ensuring that the disc is not displaced during insertion. The instrumentation will simultaneously remove the required volume of remaining disc and prepare the adjacent vertebral bodies for the threaded construct. Anterior osteophytes adjacent to the interspace should be removed in order to ensure accurate seating of the instrumentation against the vertebral bodies.

Surgical Technique

STEP 1

6

Intraoperative Sizing, Alignment & Templating

The center of the disc should be located and marked with the assistance of fl uoroscopy.

Note: Two methods are available for preparing the disc space if threaded constructs are to be used. One requires vigorous resection of the annulus and disc material while the other uses Trephines to make properly spaced annulotomies in the disc space.

Block Discectomy Method (Complete Disc Excision)

The Block Discectomy Method is the preferred method. First the Centering Pin should be used to fl uoroscopically confi rm the midline of the disc. A mark is then placed in the midline on the vertebral body cephalad to the Centering Pin (Figures 1a–1c).

Figure 1a

Figure 1b

Figure 1c

Surgical Technique

STEP 2

7

INTRAOPERATIVE SIZING, ALIGNMENT & TEMPLATING

Block Discectomy Method, continued

Using the blunt proximal end of the appropriate size Double Barrel Outer Sleeve, measure the available space for the selected construct size. Compare this to the preoperative radiographic templating process to fi nalize the size selection.

Continuing to hold the double barrel, identify and mark the necessary width of discectomy (Figure 2a). Using a scalpel, Rongeur, and Curette, remove the disc material from the defi ned space. Use care to avoid removing too much annulus laterally or posteriorly (Figure 2b).

Note: If a single construct must be used, the surgeon may use the proximal end of the single barrel as a guide for identifying the available space and beginning the discectomy in preparation for placement of the single construct. Preferred placement always includes use of dual constructs.

The procedure proceeds with size-specifi c instrumentation for the appropriate diameter threaded construct.

Figure 2a

Surgical Technique

STEP 2

Figure 2b

8

Figure 3

Figure 4

Surgical Technique

STEP 2Intraoperative Sizing, Alignment & Templating

First, the center of the disc should be located and marked with the assistance of fl uoroscopy (as shown on page 6).

Trephining Method (Annulotomy Method)

Using the appropriate size Template (16mm, 18mm, 20mm) in the deployed position, measure the available space for the selected construct size. Compare this to the preoperative radiographic templating process to fi nalize the size selection (Figure 3).

Return the Template to the undeployed position, use a Mallet to secure the Template so that the central spike rests in the midline and the lateral spikes contact the respective vertebral bodies (Figure 4).

9

INTRAOPERATIVE SIZING, ALIGNMENT & TEMPLATING

Trephining Method, continued

Using the largest Trephine size which engages disc (but not bone), core out the fi rst pilot hole (Figure 5).

Holding the top of the Template/Trephine guide with one hand, grasp the color-coded handle and rotate it 180˚ to deploy the Template in the full binocular-style position (Figure 6). Repeat the trephining procedure on the opposing side to complete the bilateral pilot hole trephining. Following trephining of the pilot holes, a Rongeur may be used to remove additional disc material from the holes. Use care not to alter the location of the holes.

The bilateral holes are now prepared and should be used for orientation during the procedure.

Note: If a single threaded construct must be used, the surgeon may use the Tem-plate as a guide for placing a single trephined pilot hole. The primary reason for using a single construct would be in cases where the surgeon is unable to mobilize the neurovascular structures to obtain adequate surgical expo-sure for placement of dual constructs. Preferred placement always includes the use of dual constructs.

Figure 5 Figure 6

Surgical Technique

STEP 2

Vertebral Distraction and Annular Tensioning

Distraction Shafts are used to distract the vertebral bodies and apply tension to the annulus fi brosis prior to vertebral reaming.

The Dual-Height Distractors allow varying degrees of disc space distraction and are slightly angled to help restore lumbar lordosis. The Distractors should be inserted so the smallest diameter (and greatest taper) is parallel to the disc space (Figure 7a). Additional annular tension and disc height is achieved by attaching the T-handle (Figure 7b) and rotating the Distractor 90º to achieve the full distraction height potential of the selected Shaft (Figure 7c).

If two Distractors are to be used, they should be placed in a manner that will allow the central extension of the Double Barrel Outer Sleeve to be seated in the midline. Both Distractors should be initially seated, the T-handle attached to the respective Shafts and subsequently rotated. Following this step, the surgeon is ready to place the Double Barrel Outer Sleeve.

The surgeon may fi nd it easiest to use a Single Distractor Shaft placed directly in the midline. After the T-handle is rotated 90º and full distraction height is established, the Distractor is removed and the appropriately sized Double Barrel Outer Sleeve is immediately placed so the central extension is in the midline, to maintain the disc space height.

The following dual height Distractors are provided within the corresponding instrument sets: 16mm instruments = 8/10mm Distractor 18mm instruments = 10/12mm Distractor 20mm instruments = 12/14mm Distractor

Fluoroscopic control is helpful in assessing distraction and may be used to confi rm correct location and orientation of the Distractors. Since the Distractor acts as a centering post and alignment guide for the procedure, it is essential that it be located properly.

10

Figure 7a

Figure 7c

Figure 7b

Surgical Technique

STEP 3

Outer Sleeve Placement

The Double Barrel approach (preferred) as well as the Single Barrel approach (alternative) are described below.

Note: Prior to fully seating the Outer Sleeve, all neurovascular structures should be accurately identifi ed and adequately retracted. Intraoperative fl uoroscopy is useful in confi rming that the Outer Sleeve is fully seated against the vertebral bodies and properly oriented within the disc space.

Double Barrel Technique

Firmly seat the Double Barrel Outer Sleeve into the disc space and against the vertebral bodies using the Double Driver Cap (Figure 8). The windows on the Double Barrel Outer Sleeve may be oriented either caudal or cephalad depending upon surgeon preference. Confi rm that the Sleeve is fully seated and properly oriented using fl uoroscopy.

The Double Barrel Outer Sleeve includes a central, angled intradiscal extension that coincides with the angle and width of the Distractor Shaft. If the Trephining (annulotomy) method was used, insertion of this extension may require a more extensive discectomy to allow space for its insertion. The central extension is for both engaging adjacent vertebral bodies and maintaining distraction of the disc space. The lateral extensions are smaller than the central extension and are intended only to aid in keeping soft tissue and vascular structures from slipping under the lateral margins of the Outer Sleeve (Figure 9). After placing the Double Barrel Outer Sleeve, remove the Distractors using the T-handle for leverage and for counter-rotating to the smaller height if necessary.

11

Figure 8

Figure 9

Surgical Technique

STEP 4

Outer Sleeve Placement

Single Barrel Technique

Note: A Single Barrel Outer Sleeve may be used if a single threaded construct must be used, or if the surgeon prefers to place bilateral constructs without using the Double Barrel technique.

After the distraction procedure, place the Single Barrel Outer Sleeve over the Distractor and seat fi rmly into the disc space and against the vertebral bodies using the Single Driver Cap (Figure 10).

The Single Barrel Outer Sleeve includes two lateral, angled intradiscal extensions that coincide with the angle and height of the Distractor. These extensions are for both engaging adjacent vertebral bodies and maintaining distraction of the disc space.

After placement of the Single Barrel Outer Sleeve, remove the Distractors using the T-handle for leverage and for counter-rotating to the smaller height if necessary.

12

Figure 10

Surgical Technique

STEP 4

Vertebral Reaming

Note: The appropriate sized hollow Reamer is used to prepare the disc space for placement of the threaded constructs.

Attach the Depth Stop to the Reamer as follows. While holding both the knurled sections of the Depth Stop with both hands, pull down on the proximal portion allowing the Depth Stop to move freely over the depth grooves. Slide the Depth Stop down until the square window is showing the etched depth markings on the shaft of the Reamer (Figure 11).

Once the window is over the desired depth marking, release the proximal knurled portion of the Depth Stop allowing it to spring back and to lock in this position. Verify that the desired depth still appears in the window.

Note: The Depth Stop may need to be rotated to view the depth in the window.

The appropriate Depth Stop setting should be chosen based on the preoperative templating using axial CT or MR images and verifi ed using intraoperative fl uoroscopy. The depth selected should refl ect the length of the threaded construct and the depth of the countersinking desired.

Figure 11

13

Surgical Technique

STEP 5

Vertebral Reaming

The T-handle is attached and the assembly is inserted into the appropriate Outer Sleeve and advanced in a clockwise motion until the Depth Stop contacts the top of the Outer Sleeve (Figure 12). You should not attempt to ream the entire depth with one pass of the Reamer. Several passes should be taken (cleaning the Reamer after each pass), increasing the depth of penetration during each pass until the Depth Stop makes contact with the top of the Outer Sleeve. Any sensation of bouncing during reaming should prompt removal and cleaning of the Reamer. This generally indicates that additional soft tissue is being pushed in front of the Reamer and is interfering with its action. When removing the Reamer, a continued clockwise rotation should be performed to aid in debris removal. The Reamer may be cleaned by wiping with a moist lap sponge or by placing the Cleaning Tool provided through the clean-out hole in the distal end of the Reamer. The I.V.D. Rongeur may be used between reaming passes to remove any remnant bone, disc or annular material.

Note: Lateral fl uoroscopy should be used to verify sagittal alignment while reaming.

14

Figure 12

Surgical Technique

STEP 5

Vertebral Tapping (This step may not be required for all threaded constructs.)

The Depth Stop is placed on the Tap as previously described (Figure 11). The depth should be no greater than the depth set on the Reamer, and in most cases, the Reamer and the Tap will be set at the same depth. Advance the Tap manually until the positive stop contacts the top of the Outer Sleeve (Figure 13).

Note: Rotating the Tap further will result in stripping of the threads. Confi rm the appropriate depth both fl uoroscopically and visually. The Tap must be removed by counter-rotation to preserve the prepared threads. It is important that the Tap only be inserted once. Once the Tap is removed, additional passes should not be attempted because they may strip the prepared threads in the vertebral endplates. To remove the Tap, rotate in a counter-clockwise direction.

Note: Lateral fl uoroscopy should be used to verify sagittal alignment while tapping.

15

Figure 13

Surgical Technique

STEP 6

16

Threaded Construct Placement

Attach the appropriate size of threaded construct to the corresponding Inserter Shaft. The Shaft is designed to engage the construct with a slotted and a threaded interface.

Thread the construct onto the Holder by turning the knurled knob to fi x the construct securely and align the slot (Figure 14).

Note: The depth markings on the Inserter Shaft are used to determine the amount of countersink.

Turning the Driver in a smooth controlled fashion, advance the construct in a clockwise direction using gentle downward pressure until the desired countersink depth is reached (Figure 15a). As the construct nears proper insertion depth, resistance will be encountered because of the precise fi t with the vertebral endplates. Do not continue to advance the construct if noticeable resistance is encountered prior to the proper anticipated depth. This usually indicates either cross threading or the presence of debris being pushed in front of the construct. Continued insertion of the construct could lead to stripping of the threads, breakage or damage to the host/construct interface. If premature resistance is encountered, remove the construct. Reconfi rm depth measurements and confi rm that the prepared hole is clear of debris.

The fi nal placement of the construct should be such that the T-handle rests in a position parallel to the disc space (Figure 15b). In addition, the T-handle in the parallel orientation will ensure the opening of the construct is facing in an optimal orientation. Final position should be confi rmed with lateral fl uoroscopy. Turn the thumb wheel until it completely disengages the construct. The Inserter can then be removed easily.

Figure 15a

Figure 15b

Figure 14

Surgical Technique

STEP 7


For the Double Barrel technique; continue by repeating the reaming, tapping and insertion steps on the contralateral side and then remove the Outer Sleeve.

For the Single Barrel technique; remove the Outer Sleeve and repeat the identical steps on the contralateral side.

Tip: For easier removal of either the Double or Single Barrel instruments, snap the remover attachment into the Outer Sleeve. Attach the instrument remover (Slap Hammer) (Figure 16) and proceed with controlled removal of the Outer Sleeve (Figure 17).

17

Figure 16

Figure 17

Surgical Technique

STEP 7

Figure 18


In the fi nal position, the constructs should be slightly countersunk from the anterior surface and within the lateral margins of the vertebral bodies (Figure 18).

If necessary, the Inserter may be re-attached to the construct and used to advance it. Take care to ensure that the fi nished position of the T-handle is parallel to the disc space. To countersink the construct, adequate reaming and tapping depth must have been achieved. For example, if a 23mm length construct is being inserted, the reaming and tapping depth must be greater than 23mm to allow the construct to be countersunk. Trying to countersink in the setting of inadequate reaming and tapping may result in stripping the threads and potential loss/damage to the construct/host interface. Additionally, in a situation where a construct made of allograft bone remains prominent and can be advanced no further, a high speed air drill may be used to trim down any areas that may remain proud.

A lateral fl uoroscopic image may be taken to ensure proper fi nal placement. Where possible, pack additional bone graft around and between the constructs.

Remember: Threaded constructs typically have a central chamber which is packed tightly with autogenous bone. Surgeon discretion should determine the location and timing of the harvesting procedure. Packing the construct prior to attachment to the Inserter is recommended.

18

Surgical Technique

STEP 7

19

Closure and Postoperative Care

If transperitoneal exposure was performed, close the posterior peritoneum over the constructs.

Wound closure is carried out in a routine manner.

Ambulation begins when tolerated, usually the same day. A corset or TLSO is used postoperatively for immobilization.

Surgical Technique

STEP 8

Product Ordering Information

Product Information

20

General Instruments Item # Description

902-100 Bone Dowel Instrumentation System

(Anterior Approach) General Instrument Case

890-501 Instrument Remover, Large

890-502 Quick Disconnect T-handle (2 required)

890-521 3.5mm & 3/32 Hex Driver

893-509 T-handle Trephine, 10/6mm



894-093 Guidewire

900-300 Bone Press

902-112 Adjustable Depth Stop (2 required)

902-113 Single Driver Cap

902-114 Double Driver Cap

▲ 902-116 16mm Template



902-125 Bone Dowel Holder

902-126 Reamer Clean Out Tool

901-450 Centering Pin Shaft (2 required)

901-451 Centering Pin (2 required)

950-940 I.V.D. Rongeur, 4mm X 10mm16mm Instruments Item # Description

▲ 902-200 Bone Dowel Instrumentation System

(Anterior Approach) 16mm Instrument Case

▲ 890-544 16mm Bone Press Plug

▲ 902-216 16mm Threaded Construct Inserter

▲ 902-221 16mm Dowel Adjuster

▲ 902-223 16mm Single Barrel Remover Attachment

▲ 902-225 16mm 8/10mm Distractor (2 required)

▲ 902-230 16/8mm Single Barrel O.S. Distractor


▲ 902-235 16/8mm Double Barrel O.S. Distractor


▲ 902-240 16mm Threaded Construct Adjustable Reamer

▲ 902-241 16mm Threaded Cortical Dowel Adjustable Tap

18mm Instruments Item # Description

▲ 902-300 Bone Dowel Instrumentation System (Anterior Approach) 18mm Instrument Case












20mm Instruments Item # Description

▲ 902-400 Bone Dowel Instrumentation System (Anterior Approach) 20mm Instrument Case












Note: 63 Total Instruments for a full set of instruments (includes those

with 2 each required). All instruments sold separately.

PURPOSE:This instrument is intended for use in surgical procedures.DESCRIPTION:Unless otherwise stated, instruments are made out of a variety of materials commonly used in orthopedic and neurological procedures including stainless steel and acetyl copolymer materials which meet available national or international standards specifi cations as applied to these devices. Some instruments are made in aluminium, and some with handles made of resin bonded composites, and while these can be steam autoclaved, certain cleaning fl uids must not be employed. None of the instruments should be implanted.INTENDED USE:This instrument is a precision device which may incorporate a measuring function and has uses as described on the label.Unless labeled for single use, this instrument may be re-used.If there is any doubt or uncertainty concerning the proper use of this instrument, please contact MEDTRONIC SOFAMOR DANEK Customer Service for instructions. Any available surgical techniques will be provided at no charge.WARNINGS:The methods of use of instruments are to be determined by the user’s experience and training in surgical procedures.Do not use this instrument for any action for which it was not intended such as hammering, prying, or lifting. This instrument should be treated as any precision instrument and should be carefully placed on trays, cleaned after each use, and stored in a dry environment. To avoid injury, the instrument should be carefully examined prior to use for functionality or damage. A damaged instrument should not be used. Additional back-up instruments should be available in case of an unexpected need.MEDTRONIC SOFAMOR DANEK does not and cannot warrant the use of this instrument nor any of the component parts upon which repairs have been made or attempted except as performed by MEDTRONIC SOFAMOR DANEK or an authorized MEDTRONIC SOFAMOR DANEK repair representative.Implied warranties of merchantability and fi tness for a particular purpose or use are specifi cally excluded.POSSIBLE ADVERSE EFFECTS:Breakage, slippage, misuse, or mishandling of instruments, such as on sharp edges, may cause injury to the patient or operative personnel.Improper maintenance, handling, or poor cleaning procedures can render the instrument unsuitable for its intended purpose, or even dangerous to the patient or surgical staff.Proper patient selection and operative care are critical to the success of the device and avoidance of injury during surgery. Read and follow all other product information supplied by the manufacturer of the implants or the instruments.Special precautions are needed during pediatric use. Care should be taken when using instruments in pediatric patients, since these patients can be more susceptible to the stresses involved in their use.There are particular risks involved in the use of instruments used for bending and cutting rods. The use of these types of instruments can cause injury to the patient by virtue of the extremely high forces which are involved. Do not cut rods in situ. In addition, any breakage of an instrument or the implant in this situation could be extremely hazardous. The physical characteristics required for many instruments does not permit them to be manufactured from implantable materials, and if any broken fragments of instruments remain in the body of a patient, they could cause allergic or infectious consequences. Over-bending, notching, striking and scratching of the implants with any instrument should be avoided to reduce the risk of breakage. Under no circumstances should rods or plates be sharply or reverse bent, since this would reduce the fatigue life of the rod and increase the risk of breakage. When the confi guration of the bone cannot be fi tted with an available device and contouring of the device is absolutely necessary, contouring should be performed only with proper bending equipment, and should be performed gradually and with great care to avoid notching or scratching the device.Extreme care should be taken to ensure that this instrument remains in good working order. Any surgical techniques applicable for use of this system should be carefully followed. During the procedure, successful utilization of this instrument is extremely important. Unless labeled for single use, this instrument may be reused. This instrument should not be bent or damaged in any way. Misuse of this instrument, causing corrosion “freezing-up”, scratching, loosening, bending and/or fracture of any or all sections of the instrument may inhibit or prevent proper function.

It is important that the surgeon exercise extreme caution when working in close proximity to vital organs, nerves or vessels, and that the forces applied while correcting the position of the instrumentation is not excessive, such that it might cause injury to the patient.

Excessive force applied by instruments to implants can dislodge devices, particularly hooks.Never expose instruments to temperatures in excess of 134º C that may considerably modify the physical characteristics of the instruments.CAUTION: FOR USE ON OR BY THE ORDER OF A PHYSICIAN ONLY.CAUTION: FEDERAL (U.S.) LAW RESTRICTS THESE DEVICESTO SALE BY OR ON THE ORDER OF A PHYSICIAN ONLY.This device should be used only by physicians familiar with the device, its intended use, any additional instrumentation and any available surgical techniques.For the best results MEDTRONIC SOFAMOR DANEK implants should only be implanted with MEDTRONIC SOFAMOR DANEK instruments.Other complications may include, but are not limited to:1. Nerve damage, paralysis, pain, or damage to soft tissue,

visceral organs or joints.2. Breakage of the device, which could make necessary removal

diffi cult or sometimes impossible, with possible consequences of late infection and migration.

3. Infection, if instruments are not properly cleaned and sterilized.4. Pain, discomfort, or abnormal sensations resulting from the

presence of the device.5. Nerve damage due to surgical trauma.6. Dural leak in cases of excessive load application.7. Impingement of close vessels, nerves and organs by slippage

or misplacement of the instrument.8. Damage due to spontaneous release of clamping devices or

spring mechanisms of certain instruments.9. Cutting of skin or gloves of operating staff.10. Bony fracture, in cases of deformed spine or weak bone. 11. Tissue damage to the patient, physical injury to operating

staff and/or increased operating time that may result from the disassembly of multi-component instruments occurring during surgery.

OTHER PRECAUTIONS:1. Excessive forces when using bending or fi xation instruments

can be dangerous especially where bone friability is encountered during the operation.

2. Any form of distortion or excessive wear on instruments may cause a malfunction likely to lead to serious patient injury.

3. Regularly review the operational state of all instruments and if necessary make use of repair and replacement services.

DEVICE FIXATION:Some surgeries require the use of instruments which incorporate a measuring function. Ensure that these are not worn, that any surface engravings are clearly visible.Where there is a need for a specifi ed tightening torque, this may normally be achieved with torque setting instruments supplied by MEDTRONIC SOFAMOR DANEK; the pointer on these instruments must indicate ZERO before use. If not, return for recalibration.With small instruments, excess force, beyond the design strength of the instrument, can be caused even by simple manual overloading. Do not exceed recommended parameters.To determine the screw diameter with the screw gauge, start with the smallest test hole.PACKAGING:MEDTRONIC SOFAMOR DANEK instruments may be supplied as either sterile or non- sterile. Sterile instruments will be clearly labeled as such on the package label. The sterility of instruments supplied sterile can only be assured if the packaging is intact.Packages for both sterile and non-sterile components should be intact upon receipt. All sets should be carefully checked for completeness and all components should be carefully checked for signs of damage, prior to use. Damaged packages or products should not be used and should be returned to MEDTRONIC SOFAMOR DANEK.Remove all packaging material prior to sterilization. Only sterile implants and instruments should be used in surgery. Always immediately re-sterilize all instruments used in surgery. Instruments should be thoroughly cleaned prior to re-sterilization. This process must be performed before handling, or before returning product to MEDTRONIC SOFAMOR DANEK .

DECONTAMINATION AND CLEANING:All instruments should be thoroughly cleaned before sterilization using established hospital methods. This includes the use of neutral cleaners followed by deionized water rinse.Note: certain cleaning solutions such as those containing caustic soda, formalin, glutaraldehyde, bleach and/or other alkaline cleaners may damage some devices, particularly instruments; these solutions should not be used.Also, certain instruments may require dismantling before cleaning.All instruments should be treated with care. Improper use or handling may lead to damage and possible improper functioning of the instrument.

EXAMINATION:Instruments must always be examined by the user prior to usein surgery.Examination should be thorough, and in particular, should take into account a visual and functional inspection of the working surfaces, pivots, racks, spring or torsional operation, cleanliness of location holes or cannulations, and the presence of any cracks, bending, bruising or distortion, and that all components of the instrument are complete.Never use instruments with obvious signs of excessive wear, damage, or that are incomplete or otherwise unfunctional. STERILIZATION:Unless supplied sterile and clearly labeled as such, this instrument must be sterilized before use. If the product described in this document is sterilized by the hospital in a tray or case, it must be sterilized in a tray or case provided by Medtronic Sofamor Danek.

MEDTRONIC SOFAMOR DANEK instruments for use with internal spinal fi xation implants must be steam sterilized according to the following process parameters: METHOD CYCLE TEMPERATURE EXPOSURE TIME Steam Gravity 121 C (250º F) 30 min.

Steam Pre-Vacuum 132 C (270º F) 4 min.

For use of this product and instruments outside the United States, some non-U.S. Health Care Authorities recommend sterilization according to these parameters so as to minimize the potential risk of transmission of Creutzfeldt-Jakob disease, especially of surgical instruments that could come onto contact with the central nervous system: METHOD CYCLE TEMPERATURE EXPOSURE TIME

Steam Pre-Vacuum 134 C (273º F) 18 min.

OPERATIVE USE:The physician should take precautions against putting undue stress on the spinal area with instruments. Any surgical technique instruction manual should be carefully followed. REMOVAL OF IMPLANTS:For the best results, the same type of MEDTRONIC SOFAMOR DANEK instruments as used for implantation should be used for implant removal purposes. Various sizes of screwdrivers are available to adapt to the removal drive sizes in auto break fi xation screws.It should be noted that where excessive bone growth has occurred, there may be added stress on the removal instruments and the implants. Both instrument and implant may be prone to possible breakage. In this case it is necessary to fi rst remove the bone and/or tissue from around the implants.FURTHER INFORMATION:In case of complaint, or for supplementary information, please see the address page of this information sheet.PRODUCT COMPLAINT:Any Health Care Professionals (e.g., customer users of MEDTRONIC SOFAMOR DANEK instruments), who have any complaint or who have experienced dissatisfaction in the product quality, identity, durability, reliability, safety, effectiveness and/or performance, should notify the distributor, MEDTRONIC SOFAMOR DANEK. Further, if any instrument malfunctions, (i.e., does not meet any of its performance specifi cations or otherwise does not perform as intended), or is suspected of doing so, the distributor or MEDTRONIC SOFAMOR DANEK should be notifi ed immediately. If any MEDTRONIC SOFAMOR DANEK product ever malfunctions and may have caused or contributed to the death or serious injury of a patient, the distributor or MEDTRONIC SOFAMOR DANEK should be notifi ed as soon as possible by telephone, FAX or written correspondence. When fi ling a complaint, please provide the component(s) name and number, lot number(s), your name and address, and the nature of the complaint.

© 2005 MEDTRONIC SOFAMOR DANEK USA, Inc.All Rights Reserved.

Important Information ConcerningMedtronic Sofamor Danek Instruments

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MLITANTST5IRN1782/016©2005 Medtronic Sofamor Danek USA, Inc. All Rights Reserved.

MEDTRONIC SOFAMOR DANEK USA, INC.Spinal Division Worldwide Headquarters1800 Pyramid PlaceMemphis, TN 38132(901) 396-3133(800) 876-3133Customer Service: (800) 933-2635

www.sofamordanek.comFor more information go to www.myspinetools.com

The surgical technique shown is for illustrative purposes only. The technique(s) actually employed in each case will always depend upon the medical judgement of the surgeon exercised before and during surgery as to the best mode of treatment for each patient.

ANTERIOR INSTRUMENTATION · Figure 7b Surgical Technique STEP 3. Outer Sleeve Placement The Double...

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Transcript of ANTERIOR INSTRUMENTATION · Figure 7b Surgical Technique STEP 3. Outer Sleeve Placement The Double...