PSI Patient Specific Implant. Derivedfrom CT data for excellent reconstructiveresults.

ProductInformation

Synthes 1

Table of Contents

PSI Patient Specific Implant 2

Choice of Material 4

Quotation Process 6

WarningThis description is not sufficient for immediate application ofthe instrumentation. Instruction by a surgeon experienced inhandling this instrumentation is highly recommended.

2 Synthes PSI Patient Specific Implant

PSI Patient Specific Implant. Derivedfrom CT data for excellent reconstructiveresults.

Patient Specific ImplantIntended for replacement of bony voids in the cranial/craniofacial skeleton.

Features– Better anatomic fit versus conventional fixation/

reconstruction methods– Reduced operating time– Satisfying aesthetic results for surgeon and patient

Synthes Patient Specific Implants are derived from CT datawhich is obtained from the hospital radiology department.

Validated process is used to convert and manipulate the CT data to create an anatomically correct skull model and an implant model.

Synthes 3

Surgeons can choose from two methods of reviewingSynthes implant design prior to fabrication of implant:1. Skull model and implant model are sent to surgeon

for review, mark up and/or approval. 2. Computer images of the defect, the implant and the

implant fitted into the defect are sent electronically.

Surgeons have a choice of two biocompatible materials: – PEEK Optima-LT (polyetheretherketone) or – Commercially pure titanium

When final implant design is determined and a purchaseorder has been received, Synthes will fabricate one non-sterile implant for shipment to the surgeon.

Choice of Material

Titanium (commercially pure, implant grade)

Features– Ultra high strength– Radioopaque– Machine screws (488.066) are needed

(See graphics page 5).– Screw hole position is defined during the

design process.

PEEK Optima-LT (polyetheretherketone)

Features– Engineered for strength, stability and biocompatibility– Radiolucent (minimal MRI artifact)– Bone-like stiffness and strength– Surgeon can determine plate and screw

placement during surgery– Light weight– Autoclavable – withstands repeated sterilization– Can be used with Synthes standard 1.3 mm to

2.0 mm cranial and craniofacial fixation systems– Minimum thickness of implant is 3 mm

4 Synthes PSI Patient Specific Implant

Synthes 5

PEEK Mechanical PropertiesCortical Bone PEEK

Modulus of Elasticity (stiffness) (GPa) 8–24 3.6–4.1

Yield Strength (MPa) 115 113

Sterilization Method

Method Cycle Temperature Exposure Time

Steam Gravity 132–135°C 10 MinutesDisplacement (270–275°F)(Wrapped)

Steam Pre-vacuum 132–135°C 4 Minutes(Wrapped) (270–275°F)

Notes regarding the use of PEEK Patient SpecificImplantsFor minor fit modifications it is suggested that the surgeonmodify the patient bone rather than modifying the PEEKPatient Specific Implant. If needed, PEEK Patient Specific Im-plants can be modified with a high speed burr. It is suggestedthat the PEEK implants be modified and rinsed in sterile salinesolution away from the implant/surgical site, to ensure thatparticulate debris does not infiltrate the surgical site after anymodifications.

Standard plates and self-tapping or self-drilling screws canbe used to attach the PEEK Patient Specific Implant to thepatient. Screw holes, regardless of screw size and type, mustbe predrilled away from the surgical site.

Titanium Mechanical PropertiesCorticalBone Ti-grade 2

Modulus of Elasticity (stiffness) (GPa) 8–24 103

Yield Strength (MPa) 115 230 min.

Sterilization Method

Method Cycle Temperature Exposure Time

Steam Gravity 132–135°C 10 MinutesDisplacement (270–275°F)(Wrapped)

Steam Pre-vacuum 132–135°C 4 Minutes(Wrapped) (270–275°F)

BoneTitanium PSI Implant

1.6 mm TitaniumMachine Screw(488.066)

LPN Bone Screw

6 Synthes PSI Patient Specific Implant

Quotation Process

1

Surgeon sends patient to radiology to be scanned accordingto Synthes CT Scanning Protocol.

2

Surgeon sends to Synthes:1. The completed Request for Quote form.2. CT scan according to the CT Scanning Protocol.

Notes– Scans must be less than four months old. Films will not

be accepted.– Patient’s CT scan and any additional patient information

will be used solely for the production of a Patient SpecificImplant. All patient information will be kept confidential.

– The data can either be sent by mail (express) or can beuploaded through an Internet connection. Contact yourSynthes representative for details.

For questions please call Synthes Headoffice (Tel. +41 61 96 56 111) and ask for CMF Patient Specific Implant Department orcontact your local Synthes representative.

Surgeon name Hospital name

Exact shipping address

City and post code Country

Phone Alternative phone

E-Mail address Alternative e-mail address

Secondary contact name Secondary phone number

Secondary e-mail address

Patient number/name Date of planned surgery

Implant material (please choose one) □ PEEK □ Titanium

(Special machine screws are needed for fixation of

the implant sides and will be charged separately)

Review method (please choose one) □ CAD drawing □ Skull model

(An additional charge of 250 up to 500 USD will be

added for skull model review)

Approximate defect location and shape

Approx. defect size:

□ I have included the CD-Rom with the CT scan and marked it as follows: □ Scanner type□ Date of scan□ Patient number/name

Note: An upload of the data through an Internet connection is also possible.

Please contact your Synthes representative for more information.

Date/Signature

Request for QuotePSI Specific Implant

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Synthes GmbH

CMF Patient Specific Implant

4436 Oberdorf

Switzerland

Matrix 512�512

Slice thickness 1.0 mm

Feed per rotation 1.0 mm

Reconstructed slice increment 1.0 mm

Reconstruction algorithm Bone or high resolution

Gantry tilt 0°

Accepted media CD

Please forward completed scan (DICOM slices) to

surgeon. Note on disc: scanner type, date of scan, pa-

tient number/name, surgeon, hospital, contact number.

This document describes the guidelines for a CT scan that is taken for the purpose of ordering a

Patient Specific Implant from Synthes. See back of page for supported scanners.

Preparation of the patient

□ Remove any non-fixed metal dentures or jewellery in and near the region to be scanned.

Non-metallic dentures may be worn during scan.

□ Place the patient supine on the scanner table.

□ Instruct the patient not to move.

Aligning the patient

□ Scan the patient without gantry tilt (0° angulation).

□ If this is not possible mark the degree of angulation on the scan.

Be aware that 3D representation will have an inferior quality due to the tilt.

□ Align the patient in a way that prevents as many artefacts as possible.

□ Use a head holder to stabilize the position and strap the head securely to prohibit motion.

Scanning instructions

□ Set the table height so that the area to be scanned is centred in the scan field.

□ All slices must have the same field of view, the same reconstruction centre and the same table height.

□ Scan all slices in the same direction.

□ Scan with the same slice spacing: slice spacing must be less than or equal to the slice thickness.

Slice thickness should preferably not be larger than 1 mm.

□ Scan the entire defect as well as 2 cm above and below.

□ If high-quality reformatted images from overlapping axial slices are required it is suggested that

additional scans be performed separately.

Reconstruction of the images

□ Use the sharpest reconstruction algorithm available, usually described as a bone or high-resolution algorithm.

□ Reconstruct the images with a 512�512 matrix.

□ Only the axial images are required.

□ Send the images to the surgeon.

□ Data or media other than CD will prolong the quoting process, due to added conversion time.

CT Scanning ProtocolPSI Patient Specific Implant

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Synthes 7

1 23Synthes designs the implant and prepares a quote.

Review and approval of the design can be done in one oftwo ways:1. A skull model and an implant model are shipped.2. Computer images of the defect, the implant and the

implant fitted into the defect are sent electronically.

The quote and the computer images will be sent out to the surgeon.

Note: If the CT data cannot be reconstructed into a 3-Dformat, Synthes will request a modified scan. If the defectis not clearly defined, Synthes will contact the surgeon toverify the margins of the defect. In both instances additionaltime will be needed.

Most defects have borders which are clearly defined on the CT scan, and a quotation can be prepared upon receiptof the scan and the Request for Quote form.

Partially resorbed bone within the defect area (highlightedred) will require consultation with the surgeon to define theimplant configuration before the quotation process can begin.

8 Synthes PSI Patient Specific Implant

5

When the form Order for Custom Made Device is received,Synthes starts manufacturing the implant. One non-sterileimplant will be shipped to the surgeon.

4

Surgeon accepts the PSI quotation and issues a purchase order to Synthes by signing the form Order for CustomMade Device.

Prompt approval of the design is required for the implant tobe manufactured in a timely fashion. If changes are requiredat this stage, the model will be modified, reviewed and approved by the surgeon again. This will delay the start ofimplant manufacture.

Synthes GmbH Eimattstrasse 3 Tel +41 61 965 63 26CH- 4436 Oberdorf Fax +41 61 965 66 13

Switzerland

QMD-FO SE_019374 AA CH1VOSLI 29.08.2005 300 Freigegeben Seite 1 von 2

Order for Custom Made Device Bestellung Sonderanfertigung

Surgeon and Patient / Arzt und Patient

Treating Surgeon / Behandelnder Arzt: ___________________________________________________________________

Hospital / Spital: ___________________________________________________________________

Date of Surgery / Operationsdatum: ___________________________________________________________________

Name of Patient / Patientenname: ___________________________________________________________________

Specifications Custom Made Device / Anforderungen Sonderanfertigung

Specifications according request dated / Anforderungen gem. Anfrage vom : _______________________________________

Other specifications / andere Anforderungen: ____________________________________________________________

Application / Anwendung

Intended Operation Technique / Beabsichtigte Operationstechnik:

_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Previous Application / Bisherige Anwendung:

________________________________________________________________________________________________________________________________________________________________________________________________________________

_______________________________________________

Reason for the Custom Made Device / Grund für die Sonderanfertigung:

_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

By signing this agreement, the customer confirms that no standard product is available for adequate treatment of the above-mentioned patient, andthat the information on page 2 has been complied with. It is also confirmed that, prior to surgery, the patient will be extensively briefed about thespecial conditions which may arise from use of the Custom Made Device described here.

Mit der Unterzeichnung dieses Formulars bestätigt der Besteller, dass zur adäquaten Versorgung des oben genannten Patienten kein Standardprodukt erhältlich ist und die Hinweise auf Seite 2 befolgt werden. Zudem wird bestätigt, dass der Patient über die besonderen Umstände,

welche sich aus der Verwendung der hier beschriebenen Sonderanfertigung ergeben, vorgängig zur Operation umfassend orientiert wird.

Signature of the treating Surgeon:

Unterschrift des behandelnden Arztes: _____________________________________

Place and Date / Ort und Datum: _____________________________________

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