PATIENT SPECIFIC PLATES FOR MANDIBLE Custom made plates for trauma and reconstruction

PATIENT SPECIFIC PLATES
FOR MANDIBLE
Custom made plates for trauma
and reconstruction
Derived from patient CT data
Customizable design features
Strength with low profile
This publication is not intended for distribution in the USA.
PRODUCT OVERVIEW
INTRODUCTION
TRUMATCH® CMF Solutions seamlessly integrate virtual
surgical planning, intraoperative patient specific tools
and personalized implants to help achieve surgeon’s
goals of accuracy, efficiency and patient benefit.
The design of the TRUMATCH CMF Patient Specific
Plates for Mandible is individually engineered to meet
the needs of each patient and surgeon. By selecting
plate design f­ eatures, surgeons can customize the
reconstruction plate to create a patient specific solution.
The Patient Specific Plates for Mandible are manufactured to the planned patient anatomy, eliminating the
time needed for intraoperative adaption and creating
a stronger plate* with a lower overall profile.
INTENDED USE AND INDICATIONS
Intended use
Patient Specific Plates for Mandible are intended for oral,
maxillofacial surgery.
Indications
• Trauma
• Reconstructive surgery
Clinical applications may include
• Comminuted fractures
• Fractures of edentulous and atrophic mandibles
• Unstable and/or infected mandibular fractures
• Primary and secondary mandibular reconstruction
(used with vascularized or non-vascularized bone graft)
• Temporary bridging with delayed secondary reconstruction
*
Patient Specific Plates for Mandible fatigue testing data shows increased
fatigue life of both 2.0 and 2.5 mm profiles in comparison with Matrix­
MANDIBLE 2.5 mm thick plates. Test data does not indicate clinical
performance. Test data on file at Synthes.
**
Manufactured by Materialise and distributed by DePuy Synthes. For full
description of TRUMATCH CMF Solutions visit www.trumatchcmf.com
FEATURES AND BENEFITS
Derived from patient CT data
Design fits the planned outcome for easy positioning of
the grafts at the planned location.
Integration with TRUMATCH CMF virtual surgical planning service** for seamless transfer of the surgical plan
into the OR, using TRUMATCH CMF patient specific
surgical guides** with built-in drill guides that align with
the plate holes (optional).
Customizable design features
Screw hole positions and angulations defined individually to avoid screw interference with nerves, tooth roots,
osteotomies, existing or future implants.
Screw length prediction and pre-visualization of screw
trajectories to ensure a collision free construct.
Strength with low profile
2.0 mm and 2.5 mm plate thicknesses for improved
fatigue strength* with lower profiles compared to standard
reconstruction plates.
DESIGN EXAMPLES
Reconstruction involving one angle
Angle to angle plates
Condyle to condyle plates
PATIENT SPECIFIC PLATES
FOR MANDIBLE
DESIGN STEPS
Choose plate profile
The Patient Specific Plates for Mandible are available
in two plate profiles:
• 2.0 mm thick
• 2.5 mm thick
2.5 mm
8.0 mm
2.0 mm
Design plate
Plates are designed to meet the planned outcome
anatomy, originating from:
• Virtual surgical plan
• CT scan data
• Independent planning, completed using a virtual surgical plan and submitted with an STL file
Select screw hole pattern relative to
• Planned osteotomy or resection site
• Patient anatomy, for example tooth roots and nerves
• Existing or future implants, such as plates, screws or
dental implants
Define additional features
• Use with MatrixMANDIBLE Condylar Head
Add-on, if needed
Define additional features
• TRUMATCH CMF patient specific surgical
guides** with built-in drill guides that align
with the plate holes, for planned cases
Surgical Guide **
Max. 15º
Define screw hole angulation
• Angulations of 0° to 15°
• MatrixMANDIBLE conical
threaded screw holes
WORKFLOW
1 PLACE REQUEST
Patient Specific Plates
Request for service:
Mandible plates
Patient Specific Plates
Request for service:
Mandible Plates
Hospital name
Additional information:
Draw on diagram:
1. Resection lines and bone graft segments
2. Plate position (see Note 4)
3. Screw holes position in native bone and graft (spare holes included)
4. Indicate screw preferences using the screw coding defined in the inset
Exact shipping address
Screw coding
Diameters (mm): 2.0, 2.4, 2.9
Length: Bicortical / Monocortical
Type: Locking / Non-locking
Example bicortical locking screw:
2.4 BL = 2.4 mm
Sales consultant
Patient number/name
Date of planned surgery (YYYY/MM/DD)
The information requested on this page is mandatory.
Patient anatomy data provided via:
� Synthes ProPlan CMF. Case ID:
� Need ProPlan CMF planning session
(use form 036.001.287)
� STL file of the planned outcome (provided to Synthes)
� Plate shall be designed to native anatomy (see Note 1)
Plate thickness:
� 2.0 mm (see Note 2)
Standard configuration desired:
� Yes, design plate per standard configuration as defined
in Note 3.
� No, plate configuration specified in the next section(s).
� 2.5 mm
Other requests (require web-based design session):
1. Screw angulation. Identify on the diagram above the screw holes that require angulation for improved access and/or
increased stability. The exact angulation has to be defined via the web based design session with Synthes.
2. Special requirements (planned dental implants, etc). If dental implants are planned, mark their approximate position
on the diagram above
For additional information, refer to next page or propose a date for a web-based design session
(YYYY/MM/DD)
Note:
4. Indicate the relative position of the plate with respect to inferior/posterior border if different than the alignment defined
by the standard plate configuration.
10/2012
Important:
– Some clinical situations may require extending the resection beyond the planned limits; consider this when defining the
number of screws and the position of the screws next to the osteotomy in native bone.
– Please follow CT scan protocol provided by Synthes. Upload the data through an internet connection or ship it per mail.
Send the request for custom made device form per mail, e-mail or fax. For more information contact your Synthes
representative, visit our website or give us a call.
Save
Synthes GmbH
Eimattstrasse 3
4436 Oberdorf
Switzerland
www.synthesCSS.com
Email [email protected]
Phone +41 61 965 6166
Fax
+41 61 965 6602
version AA
Notes:
1. If virtual planning is not desired and the reconstruction plan is done using other options (e.g. gap bridging, mirroring of
opposite side with intra-op graft design, etc.), a web-based design session with Synthes may be necessary. This depends
on case complexity. The pre-operative CT scan should be made available to Synthes prior to the design session.
2. The 2.0 mm thick plate can be used for reconstruction with vascularized and non-vascularized bone graft
3. Standard plate configuration
− Minimum distance between two adjacent holes: 8 mm (unless otherwise indicated on diagram)
− Minimum number of screw holes: 4 per native bone and 2 per graft segment (unless additional information
provided)
− No collision among screws as long as threaded drill guides are used (or cutting guides with built in drill guides where
applicable)
− Will be aligned with the inferior and posterior border of the mandible and graft segments
Subject to modifications
Secondary phone number
Secondary e-mail address
Synthes is a trademark of Synthes, Inc. or its affiliates
E-mail address
Secondary contact name
© Synthes, Inc. or its affiliates
Phone number
Country
60100672
City and post code
2/2
036.001.564
Surgeon name
2 DESIGN PLATE
1/2
A Request for Service form must be
completed to initiate an order for a Patient
Specific Plate for Mandible. The Request for
Service form can be obtained via:
• Download from www.trumatchcmf.com
• Your local DePuy Synthes representative.
Follow the instructions on the Request for
Service form for submitting applicable
patient data, including but not limited to, CT
or CBCT data.
Patient Specific Plates for Mandible are
designed based on the information provided
in the first step via the Request for Service
form.
Some cases may require an Interactive Design Session with a DePuy Synthes engineer,
depending on the complexity of the case, or
the type of products and services requested.
The Interactive Design Session is hosted by a
DePuy Synthes engineer. During this session,
the engineer will coordinate the details for
the plate design with the surgeon and provide a first draft proposal.
3 APPROVE CASE REPORT(S)
Hole ID
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
Length* (mm)
10
12
10
10
10
10
10
10
10
10
10
18
18
10
10
10
10
10
10
10
10
10
12
Part number
03.503.045**
03.503.476 –
03.503.481**
SD900.101***
SD900.102***
Planned Screws
Diameter (mm) Lock/ Non-lock
2.4
Lock
2.4
Lock
2.4
Lock
2.0
Lock
2.0
Lock
2.4
Lock
2.4
Lock
2.4
Lock
2.4
Lock
2.4
Lock
2.4
Lock
2.4
Lock
2.4
Lock
2.4
Lock
2.4
Lock
2.4
Lock
2.4
Lock
2.4
Lock
2.4
Lock
2.4
Lock
2.4
Lock
2.4
Lock
2.4
Lock
Part number
04.503.640
04.503.642
04.503.640
04.503.610
04.503.610
04.503.640
04.503.640
04.503.640
04.503.640
04.503.640
04.503.640
04.503.648
04.503.648
04.503.640
04.503.640
04.503.640
04.503.640
04.503.640
04.503.640
04.503.640
04.503.640
04.503.640
04.503.642
Additional implants/instruments needed
Description
Drill Sleeve, long, for MatrixMANDIBLE
MatrixMANDIBLE Drill bits (∅1.5, 1.8, 2.4mm) for 03.503.045
Patient Specific Guides, Mandible
Patient Specific Guide, Fibula
Angled hole
Yes
Yes
Yes
No
No
No
No
No
No
No
No
Yes
Yes
No
No
No
No
No
No
No
Yes
Yes
Yes
Qty
1
1 each
2
1
4 MANUFACTURE & SHIP PLATE
1
2
3
23
22
21
4
20
5
6
7
19
19
18
18
17
17
8
9
10
14
11
12
16
15
13
IMPORTANT: Patient specific implants should not be bent in
anyway in order to preserve their mechanical integrity and fit
*Screw length is approximate. Surgeon will make the sole
determination of the final screw length to be used
** Included in MatrixMANDIBLE Transbuccal Instruments sets
01.503.832 and 01.503.841
***Manufactured by Materialise and distributed by Synthes
Patient Specific Plates for Mandible require
surgeon’s approval in order to proceed with
manufacture and shipment:
• For cases using virtual surgical planning**,
an initial Case Report with the planned
outcome is provided, prior to proceeding
with the plate design. The initial Case
Report must be approved via e-mail reply
by the surgeon(s) planning the case.
• Final approval of the Patient Specific Plates
for Mandible and virtual surgical planning**
Case Reports may be provided by returning
the signed Case Report(s) via fax or e-mail.
The Patient Specific Plates for Mandible Case
Report contains information about the
planned screws, if provided by the surgeon.
After the Order for Custom Made Device
form has been received, DePuy Synthes
starts manufacturing the implant.
A non-sterile or sterile implant is shipped to
the surgeon.
ORDERING PROCESS
Start
Synthes is a trademark of Synthes, Inc. or its affiliates
Feedback to
customer
OK
Quote to customer
Redesign3
Yes
No
Order
placed3
Case closed /
on hold
© Synthes, Inc. or its affiliates
No
Yes
Delivery
60100943
Manufacture
Manufacture &
Shipment
8 working days
Images for approval
1
2
3
Excluding re-design loops
Only if case was planned with ProPlan CMF
Plate and Surgical Guides (where applicable)
Ö036.001.575öAAaä
Synthes GmbH
Eimattstrasse 3
CH-4436 Oberdorf
www.depuysynthes.com
This publication is not intended for distribution in the USA.
All technique guides are available as PDF files at
www.synthes.com/lit
12/2013
Design
approved3
Approval
Depends on customer/
Follow-up
Images for approval
Subject to modifications
Design
Design3
version AB
Not OK
036.001.575
Verification
of request
Ordering
4 working days1
Request:
RFS, CT/CBCT scan,
ProPlan CMF Case
number2, STL file