Marketed by:
Manufactured by:
PROCESSING
The graft was processed in a controlled environment from a single donor.
Microbial testing was performed, where appropriate, and results met
documented acceptance criterion. The graft was released for
transplantation based on the donor eligibility determination and a review of
processing records.
Sterilization:
Puros® Demineralized Bone Matrix
For single patient use only
Cancelle™ SP is a validated bone matrix sterilization
process that inactivates potential pathogens through a
combination of chemical treatments and gamma
irradiation.
DESCRIPTION
This package contains donated human allograft tissue intended for
transplantation. Puros Demineralized Bone Matrix (DBM) combines
human DBM with a carrier that is developed using DBM from the same
donor. Puros DBM Putty with Chips contains ground cortical cancellous
chips from the same donor as the DBM and carrier. This product can be
stored at room temperature (15º-25ºC) and is ready for immediate use
without extra product preparation, (i.e. no mixing, no warming, etc). All
Puros DBM products are sterilized with low dose, low temperature
gamma irradiation.
This product is restricted to homologous use for the repair, replacement
or reconstruction of musculoskeletal defects by or on the order of a
licensed practitioner. This would include filling bone voids or gaps of the
skeletal system (e.g. dental intraosseous, oral and cranio-/ maxillofacial
defects, defects of the extremities, pelvis and spine, interbody and
posterolateral spine fusion procedures with appropriate stabilizing
hardware, etc.). Puros DBM is not intended to be used in load bearing
applications without appropriate hardware.
Because the low temperature, low dose gamma
irradiation part of the Cancelle™SP process is applied
terminally to this product, a sterility assurance level
(SAL) of 10-6 is achieved.
ADVERSE REACTIONS
Surgeons should discuss these potential adverse events with their patients.
The following complications may occur after tissue transplantation:
•
Loss of function and/or integrity of transplanted tissue due to
resorption, fragmentation, and/or disintegration including, but not
limited to, associated loss of continuity or displacement.
•
Transmission of known infectious agents including, but not limited to,
HIV, Hepatitis B, Hepatitis C, syphilis and bacteria.
•
Immune rejection of transplanted tissues; or allergic reactions to
residual chemicals.
Table 1: Composition of Products
PRODUCT DESCRIPTION
DBM
Puros DBM Putty
X
Puros DBM Putty with Chips
X
CCC
Sterile
Water
X
X
This product may contain trace amounts of any of the following chemicals:
ascorbic acid, hydrochloric acid, hydrogen peroxide, hydroxymethyl
aminomethane, isopropanol, isopropyl alcohol, povidone-iodine, silicone,
sodium hydroxide, sodium phosphate buffer.
X
DBM = Demineralized Bone Matrix
CCC= Cortical Cancellous Chips
DONOR SCREENING AND TESTING
This donated human tissue was recovered using aseptic technique from
a donor determined to be eligible for tissue donation.
After consent for donation was obtained, the tissue donor was screened
for risk factors associated with infectious diseases and medical
conditions that would rule-out donation. This screening included, but
was not limited to: Family/next-of-kin interview, medical/hospital record
evaluation, donor physical assessment and autopsy report (if performed).
The final determination of donor eligibility was made by a licensed
physician utilizing all available, relevant information.
The donor’s blood was tested by a CLIA certified laboratory utilizing test
kits approved by the FDA for donor screening and cadaveric blood
testing where applicable. The following test criteria were met for this
donor:
Table 2: Required infectious disease tests and acceptable result
BLOOD TEST
ACCEPTABLE RESULT
HIV-1 / HIV-2 Antibody
Negative/Non-Reactive
Hepatitis C Virus Antibody
Negative/Non-Reactive
Hepatitis B Surface Antigen
Negative/Non-Reactive
Hepatitis B Core Antibody (Total)
Negative/Non-Reactive
RPR for Syphilis
Negative/Non-Reactive
Human T-Cell Lymphotropic Virus I/II
Antibody
HIV-1/HCV NAT-TMA
(tested after March 2005)
HIV-1 DNA by PCR
(tested prior to March 2005)
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Negative/Non-Reactive
Negative/Non-Reactive
Negative/Non-Reactive
IFU 1 of 2
The same medical/surgical conditions that may complicate any surgical
procedure may occur during or following the transplantation of an allograft.
Zimmer and RTI, their affiliates, distributors and agents disclaim all implied
warranties concerning this tissue including any warranty of merchantability
or fitness for particular purpose. Please promptly report complaints and
possible adverse events as instructed in the Complaints section of this
insert.
WARNINGS
This product does not possess sufficient mechanical strength to support a
defect prior to soft and hard tissue ingrowths.
PRECAUTIONS
This product is contraindicated where defect stabilization is not possible.
Product should not be used when an active infection is present at the
surgical site.
RECEIPT INSPECTION
Upon arrival, unpack and/or inspect the product packaging. Verify that the
product ordered matches the product received. Should you receive an
incorrect order or find that the shipping container or product packaging
integrity is compromised, immediately notify Zimmer. Do not use product if
the sterile barrier has been compromised or the expiration date has passed.
STORAGE
Unopened product must be stored at room temperature (15º - 25ºC).
Temperature storage conditions are also stated on the package label. It is
the responsibility of the end-user to maintain products intended for
transplantation at appropriate storage conditions. It is recommended that
storage conditions be documented and controlled.
Doc # 4346 R2 10/06/09
For Use By RTI and Affiliates. This document contains product specific information, that may not be reproduced without prior written approval.
GENERAL INFORMATION
• This product is for single patient use only.
• Once opened, this product must be used for the current procedure or
discarded.
TISSUE UTILIZATION RECORD (TUR CARD)
The TUR card is designed for tracking implanted grafts. All information
provided is kept confidential and used for product tracking only. This card
must be completed by the operating room staff or clinician after the
surgery. For further instructions please see those listed on the TUR card.
Return completed copy to RTI to address or fax provided on TUR card.
• This product may not be re-sterilized.
• Do not use expired or damaged product.
• This product and all packaging materials used by RTI are latex free.
• The box is non-sterile and is used to protect the product during
shipping and storage.
• The surgeon should be familiar with the graft, surgical procedure and
any instruments prior to use of this graft or subsequent products.
CUSTOMER RETURNS AND COMPLAINTS
Please contact Zimmer at the numbers listed below for all complaints,
returns or adverse event reporting.
Phone: 1.800.777.7505
Fax:
1.800.430.9110
DIRECTIONS FOR USE:
Zimmer Dental customers please contact:
Product in a Dispenser:
Phone: 1.800.854.7019
Fax:
1.888.225.2483
1.
Remove the double packaged product, the product insert and
Tissue Utilization Record from the box.
2.
Compare the labeling identification number on the pouch with the
number on the outer box. (If the numbers do not match, do not
use the tissue)
3.
Use standard sterile technique to open the outer package and
pass inner package to sterile field.
4.
In the sterile field, open inner package, and lay out the contents.
5.
Keep dispenser capped when product is not in use.
6.
Remove cap from dispenser and dispense product as needed.
7.
Discard any unused product and single use items in accordance
with standard hospital or clinic practice for disposal of human
tissue.
Puros DBM is distributed by:
Zimmer Spine, Inc.
7375 Bush Lake Road
Minneapolis, MN 55439-2027
U.S.A
Table 3: Label symbol definitions:
EXP or
Products in a Jar:
1.
Remove the double packaged product, the product insert and
Tissue Utilization Record from the box.
2.
Compare the labeling identification number on the pouch with the
number on the outer box. (If the numbers do not match, do not
use the tissue)
3.
Use standard sterile technique to open the outer package and
pass inner package to sterile field.
4.
In the sterile field, open inner package, and lay out the contents.
5.
Keep jar lid secure when product is not in use.
6.
Remove lid and scoop product from jar.
7.
Discard any unused product and single use items in accordance
with standard hospital or clinic practice for disposal of human
tissue.
See instructions for
use
Expiration date
Storage
temperature limits
Sterile by Gamma
Irradiation
Do not reuse
Single patient use
Manufacturer
Catalogue number
Serial Number (Tissue
number)
Lot number
(Donor number)
For prescription use
only
Puros® is a registered trademark of Zimmer, Inc. or its affiliates.
CancelleTM is a trademark of RTI Biologics, Inc.
RTI Biologics, Inc.
11621 Research Circle | Alachua, FL 32615 | U.S.A
Tel: 386.418.8888 | Fax: 386.462.5533 | www.rtix.com
CTO Registration Number: RTI Biologics, Inc.100053
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IFU 2 of 2
Doc # 4346 R2 10/06/09
For Use By RTI and Affiliates. This document contains product specific information, that may not be reproduced without prior written approval.
Change Tracking Page ONLY
(386) 418-8888 • (800) 624-7238 • www.rtix.com
1.
MINIMUM AUTHORIZERS
Department ( or division designee)
2.
Revision
No.
Department( or division designee)
Regulatory Affairs Representative
Regulatory Affairs, RTI
Labeling Representative
Regulatory Affairs, RTI
Marketing Product Manager
Marketing, RTI
Zimmer Project Representative
External Approvers
Paste Department Manager,
Operations, RTI
Training Manager,
Operations, RTI
Labeling Department Manager,
Operations, RTI
Project Manager
Orthopedics & Spine, RTI
(only required for significant changes)
REVISION HISTORY
Change
Request
R2
Translation
Certificate
of Accuracy
Issue Date
Nature of Changes
N/A
10/06/09
Processing section was reworded to include description of
Cancelle™SP. The Cancelle trademark statement was
included in the IFU. The CTO number statement was
reorganized for clarity. The official Cancelle™SP logo is now
available to be placed on the label and is therefore added to
the IFU for consistency.
N/A
11/13/08
Updated company name and department authorizers vs. job
title specific authorizers. Updated donor screening and TUR
information. Adjusted grammar and sentence structure on all
sections for better readability and flow per marketing and
customers requests.
4346 R2_CRF.pdf
4346
R2_CRF(Zimmer sign
R1
CRF-4346R1.pdf
Added in additional directions for use section to
accommodate new putty product with chips and revised
direction for use section to distinguish between both types of
product containers.
R0
N/A
11/07/07
New Product. Product insert based on both current paste
insert requirements and project requirements.
CRF-4346R0.pdf
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Doc # 4346 R2 10/06/09