WARNING
Do not use this product if packaging has been opened or damaged.
DONOR SCREENING AND TESTING
Prior to donation, the donor’s blood, tissues, and medical/social history were screened for medical conditions or disease processes that would contraindicate the donation
of tissues in accordance with current FDA regulations and standards established by the American Association of Tissue Banks. The donor’s medical/social history was also
screened for HIV, Hepatitis and CJD/vCJD high risk factors in accordance with current United States Public Health Services Recommendations and FDA Federal Regulations
and Guidance Documents.
Testing of donor blood and tissue samples began at the site of recovery and continued into processing. Donor blood samples taken at the time of recovery were tested for
communicable disease by a laboratory certified to perform such testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (42 U .S.C.
263a) and 42 CFR 493, using FDA licensed tests including:
• HBsAg Hepatitis B Surface Antigen
• HBc-IgM/IgG Hepatitis B Total Core Antibody
• HCV Hepatitis C Antibody
• HIV 1/2-Ab Antibody to Human Immunodeficiency Virus Types I and 2
• RPR/STS or Equivalent Syphilis Detection
In addition to the above tests, donors recovered prior to March 9, 2005, were tested for HIV-I by p24 antigen testing or DNA Polymerase Chain Reaction (PCR) or Transcription
Mediated Amplification (TMA) Nucleic Acid Amplification Testing (NAT). Donors recovered after March 9, 2005, were tested using Human Immunodeficiency Virus Type I/
Nucleic Acid Amplification Testing (HIVI NAT) and Hepatitis C Virus/Nucleic Acid Amplification Testing (HCV NAT). Donors may or may not be tested for HTLV I/II (Human
T-Lymphotropic Virus Types I and II).
The results of all the relevant communicable disease tests referenced above were found to be negative. The communicable disease test results, together with the informed
consent, medical history interview, physical assessment, available medical records (to include previous medical history, laboratory test results, autopsy and coroner reports,
if performed), and information obtained from any source or records which may pertain to donor eligibility, have been evaluated. Based on this evaluation, the donor was
determined to meet donor eligibility criteria current at the time of recovery. The donor eligibility criteria used to screen this donor are in compliance with FDA regulations
published in 21 CFR Part 1270 “Human Tissue Intended for Transplantation” and/or Part 1271 “Human Cells, Tissues, and Cellular and Tissue-Based Products,” as applicable.
Donor eligibility was determined by one of the following tissue banks:
American Tissue Services Foundation,
Edmond, OK 73013
Musculoskeletal Transplant Foundation,
Edison, NJ 08837
Community Tissue Services,
Dayton, OH 45402
LifeNet Health,
Virginia Beach, VA 23453
RTI Biologics
Alachua, FL 32615
The names and addresses of the testing laboratories, the listing and interpretation of all required communicable disease tests, a listing of the documents reviewed as part of the
relevant medical records, and the name of the person or establishment determining the eligibility of this human tissue are on file at Medtronic and are available upon request.
The final tissue allograft product was released by Medtronic for transplantation, based on the initial donor eligibility determination and on a post-processing review and
determination that the product met all processing requirements and specifications.
VIRAL INACTIVATION
In the production of PLEXUR M® , the allograft bone is subjected to processing steps that have been shown to inactivate viruses, including HIV, hepatitis Band C and CMV.
TISSUE TRACKING
Federal (USA) regulations under 21 CFR 1271 establish requirements for tracking of human tissue products. In accordance with these regulations, the package label of each
PLEXUR M unit distributed by Medtronic bears a lot number and serial number that serve as a distinct identification code and are recorded in Medtronic’s distribution records
for purposes of tracking the tissue to the consignee or user/tissue transplant facility. The lot number and serial number should be recorded in the user/tissue transplant
facility’s records and in the tissue recipient’s medical record, along with the following information:
I. Description of Tissue
2. Lot Number (Donor ID)
3. Product Code
4. Expiration Date
5. Quantity Implanted
6. Antibiotics Used
7. Description of Procedure
8. Date and Time of Procedure
PLEXUR M® M708348B349 Rev. A
M708348B349E Rev. B
IMPORTANT INFORMATION ON PLEXUR M®
2013-05-29
Medtronic Sofamor Danek USA, Inc. SpinalGraft Technologies LLC
Memphis, TN 38132 Suite 39
Telephone 800 933 2635 (In U.S.A.) Memphis, TN 38118
901 396 3133 (Outside U.S.A.)
Fax 901 396 0356
ENGLISH
READ BEFORE USE
THIS GRAFT IS DERIVED FROM HUMAN TISSUE WHICH WAS GENEROUSLY DONATED SO THAT OTHERS MAY BENEFIT
EACH UNIT IS INTENDED FOR SINGLE PATIENT, SlNGLE PROCEDURE ONLY
CAUTION: RESTRICTED TO USE BY A PHYSICIAN
NO ADDITIONAL STERILIZATION STEP IS TO BE PERFORMED BY THE USER
DO NOT USE IF THE PACKAGE IS DAMAGED
1800 Pyramid Place 4340 Swinnea Road
IMPORTANT INFORMATION ON PLEXUR M®
DESCRIPTION
PLEXUR M® is a tissue allograft product manufactured using a composite of nondemineralized bone fibers and resorbable polymers. This product is supplied sterile for single
patient use. PLEXUR M® is provided in a solid form that is intended to be heated at the time of use to render it moldable to facilitate its placement by the surgeon at the
implant site. Upon cooling and at body temperature, PLEXUR M® returns to its natural, hard state.
DISTRIBUTED BY:
This product contains human bone tissue recovered from a cadaveric donor using aseptic surgical techniques and microbiologically tested during recovery. The tissue was
further processed under aseptic conditions and was treated with antibiotics (gentamicin). The final product, in packaged form, was sterilized using gamma irradiation.
Medtronic may also use low dose gamma irradiation as an adjunct to aseptic processing of the cadaver bone to reduce the starting bioburden. Each PLEXUR M® final product
lot was tested for endotoxins using a qualified test method.
PLEXUR M® is packaged in ready-to-use form in single patient use containers. The lot number and/or serial number, expiration date, product code, quantity (volume or
size), and additional information are listed on the package label.
INDICATIONS
PLEXUR M® is intended for use in filling bony voids or gaps of the skeletal system (i.e. extremities, pelvis) that are not intrinsic to the stability of the bony structure. These
defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone or other bony defects. PLEXUR M® may be used in conjunction
with autograft in the spine. PLEXUR M® is resorbed/remodeled and is replaced by host bone during the healing process.
CONTRAINDICATIONS
PLEXUR M® is not intended to provide structural support during the healing process; therefore, PLEXUR M® is contraindicated where the product is intended as structural
support in the skeletal system.
RELATIVE CONTRAINDICATIONS
• Severe vascular or neurological disease
• Uncontrolled diabetes
• Severe degenerative bone disease
• Pregnancy
• Presence of infection at the site
• Uncooperative patients who will not or cannot follow postoperative instructions, including individuals who abuse drugs and/or alcohol
• Hypercalcemia
ADVERSE EFFECTS
Possible adverse effects include but are not limited to:
• Wound complications, as possible with any surgery, such as hematoma, site drainage, infection, and bone fracture
• Fracture or extrusion of PLEXUR M® Bone Void Filler with or without side effects
• Deformity of the bone at the site
• Incomplete, or lack of, osseous ingrowth into bone void, as is possible with any bone void filler
Medtronic Sofamor Danek USA, Inc. SpinalGraft Technologies LLC
1800 Pyramid Place 4340 Swinnea Road
Memphis, TN 38132 Suite 39
Telephone 800 933 2635 (In U.S.A.) Memphis, TN 38118
901 396 3133 (Outside U.S.A.)
Fax 901 396 0356
IMPORTANT INFORMATION ON PLEXUR M®
READ BEFORE USE
THIS GRAFT IS DERIVED FROM HUMAN TISSUE WHICH WAS GENEROUSLY DONATED SO THAT OTHERS MAY BENEFIT
EACH UNIT IS INTENDED FOR SINGLE PATIENT, SlNGLE PROCEDURE ONLY
CAUTION: RESTRICTED TO USE BY A PHYSICIAN
NO ADDITIONAL STERILIZATION STEP IS TO BE PERFORMED BY THE USER
DO NOT USE IF THE PACKAGE IS DAMAGED
DESCRIPTION
PLEXUR M® is a tissue allograft product manufactured using a composite of nondemineralized bone fibers and resorbable polymers. This product is supplied sterile for single
patient use. PLEXUR M® is provided in a solid form that is intended to be heated at the time of use to render it moldable to facilitate its placement by the surgeon at the
implant site. Upon cooling and at body temperature, PLEXUR M® returns to its natural, hard state.
This product contains human bone tissue recovered from a cadaveric donor using aseptic surgical techniques and microbiologically tested during recovery. The tissue was
further processed under aseptic conditions and was treated with antibiotics (gentamicin). The final product, in packaged form, was sterilized using gamma irradiation.
Medtronic may also use low dose gamma irradiation as an adjunct to aseptic processing of the cadaver bone to reduce the starting bioburden. Each PLEXUR M® final product
lot was tested for endotoxins using a qualified test method.
PLEXUR M® is packaged in ready-to-use form in single patient use containers. The lot number and/or serial number, expiration date, product code, quantity (volume or
size), and additional information are listed on the package label.
INDICATIONS
PLEXUR M® is intended for use in filling bony voids or gaps of the skeletal system (i.e. extremities, pelvis) that are not intrinsic to the stability of the bony structure. These
defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone or other bony defects. PLEXUR M® may be used in conjunction
with autograft in the spine. PLEXUR M® is resorbed/remodeled and is replaced by host bone during the healing process.
CONTRAINDICATIONS
PLEXUR M® is not intended to provide structural support during the healing process; therefore, PLEXUR M® is contraindicated where the product is intended as structural
support in the skeletal system.
RELATIVE CONTRAINDICATIONS
• Severe vascular or neurological disease
• Uncontrolled diabetes
• Severe degenerative bone disease
• Pregnancy
• Presence of infection at the site
• Uncooperative patients who will not or cannot follow postoperative instructions, including individuals who abuse drugs and/or alcohol
• Hypercalcemia
ADVERSE EFFECTS
Possible adverse effects include but are not limited to:
• Wound complications, as possible with any surgery, such as hematoma, site drainage, infection, and bone fracture
• Fracture or extrusion of PLEXUR M® Bone Void Filler with or without side effects
• Deformity of the bone at the site
• Incomplete, or lack of, osseous ingrowth into bone void, as is possible with any bone void filler
WARNING AND PRECAUTIONS
of tissues in accordance with current FDA regulations and standards established by the American Association of Tissue Banks. The donor’s medical/social history was also
screened for HIV, Hepatitis and CJD/vCJD high risk factors in accordance with current United States Public Health Services Recommendations and FDA Federal Regulations
and Guidance Documents.
Testing of donor blood and tissue samples began at the site of recovery and continued into processing. Donor blood samples taken at the time of recovery were tested for
communicable disease by a laboratory certified to perform such testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (42 U .S.C.
263a) and 42 CFR 493, using FDA licensed tests including:
• HBsAg Hepatitis B Surface Antigen
• HBc-IgM/IgG Hepatitis B Total Core Antibody
• HCV Hepatitis C Antibody
• HIV 1/2-Ab Antibody to Human Immunodeficiency Virus Types I and 2
• RPR/STS or Equivalent Syphilis Detection
In addition to the above tests, donors recovered prior to March 9, 2005, were tested for HIV-I by p24 antigen testing or DNA Polymerase Chain Reaction (PCR) or Transcription
Mediated Amplification (TMA) Nucleic Acid Amplification Testing (NAT). Donors recovered after March 9, 2005, were tested using Human Immunodeficiency Virus Type I/
Nucleic Acid Amplification Testing (HIVI NAT) and Hepatitis C Virus/Nucleic Acid Amplification Testing (HCV NAT). Donors may or may not be tested for HTLV I/II (Human
T-Lymphotropic Virus Types I and II).
The results of all the relevant communicable disease tests referenced above were found to be negative. The communicable disease test results, together with the informed
consent, medical history interview, physical assessment, available medical records (to include previous medical history, laboratory test results, autopsy and coroner reports,
if performed), and information obtained from any source or records which may pertain to donor eligibility, have been evaluated. Based on this evaluation, the donor was
determined to meet donor eligibility criteria current at the time of recovery. The donor eligibility criteria used to screen this donor are in compliance with FDA regulations
published in 21 CFR Part 1270 “Human Tissue Intended for Transplantation” and/or Part 1271 “Human Cells, Tissues, and Cellular and Tissue-Based Products,” as applicable.
Donor eligibility was determined by one of the following tissue banks:
American Tissue Services Foundation,
Edmond, OK 73013
Musculoskeletal Transplant Foundation,
Edison, NJ 08837
Community Tissue Services,
Dayton, OH 45402
LifeNet Health,
Virginia Beach, VA 23453
RTI Biologics
Alachua, FL 32615
The names and addresses of the testing laboratories, the listing and interpretation of all required communicable disease tests, a listing of the documents reviewed as part of the
relevant medical records, and the name of the person or establishment determining the eligibility of this human tissue are on file at Medtronic and are available upon request.
The final tissue allograft product was released by Medtronic for transplantation, based on the initial donor eligibility determination and on a post-processing review and
determination that the product met all processing requirements and specifications.
VIRAL INACTIVATION
In the production of PLEXUR M® , the allograft bone is subjected to processing steps that have been shown to inactivate viruses, including HIV, hepatitis Band C and CMV.
TISSUE TRACKING
Federal (USA) regulations under 21 CFR 1271 establish requirements for tracking of human tissue products. In accordance with these regulations, the package label of each
PLEXUR M unit distributed by Medtronic bears a lot number and serial number that serve as a distinct identification code and are recorded in Medtronic’s distribution records
for purposes of tracking the tissue to the consignee or user/tissue transplant facility. The lot number and serial number should be recorded in the user/tissue transplant
facility’s records and in the tissue recipient’s medical record, along with the following information:
I. Description of Tissue
2. Lot Number (Donor ID)
3. Product Code
4. Expiration Date
5. Quantity Implanted
6. Antibiotics Used
7. Description of Procedure
8. Date and Time of Procedure
9. Surgeon Name
10. Any Other Pertinent Information
For European Economic Area audience only - These tissue tracking records shall be maintained for 30 years after clinical use. In case product traceability to recipient is at risk,
the customer shall secure the transfer of the records to another entity (preferably a Tissue Establishment or Organ Bank) in order to secure continued traceability. Medtronic
BV shall be informed of such a transfer of records.
HANDLING AND USE
PLEXUR M® is provided sterile and should be considered sterile unless the packaging has been opened or damaged. This product should not be resterilized. All product
heating and handling must occur in the sterile field. Strict adherence to aseptic practices must be followed during the surgical procedure to prevent product contamination.
ENGLISH
2013-05-29
DISTRIBUTED BY:
As with any surgical procedure, care should be exercised in treating individuals with preexisting conditions that may affect the success of the surgical procedure. This includes
individuals with bleeding disorders of any etiology, long-term steroidal therapy or immunosuppressive therapy.
Use this product as supplied and according to the HANDLING AND USE information provided. Do not heat PLEXUR M® using a method not described in these instructions.
Adequate fixation should be used to stabilize the implant site during hone formation and healing.
Despite the extensive tissue donor selection and qualification processes used in providing the tissue for this product, transmission of an infectious disease through the use of this
tissue is still possible. Bacterial infection at the graft site may also occur. Any adverse outcomes potentially attributable to PLEXUR M® must be reported promptly to Medtronic.
WARNING
Do not use this product if packaging has been opened or damaged.
DONOR SCREENING AND TESTING
Prior to donation, the donor’s blood, tissues, and medical/social history were screened for medical conditions or disease processes that would contraindicate the donation
of tissues in accordance with current FDA regulations and standards established by the American Association of Tissue Banks. The donor’s medical/social history was also
screened for HIV, Hepatitis and CJD/vCJD high risk factors in accordance with current United States Public Health Services Recommendations and FDA Federal Regulations
and Guidance Documents.
Testing of donor blood and tissue samples began at the site of recovery and continued into processing. Donor blood samples taken at the time of recovery were tested for
communicable disease by a laboratory certified to perform such testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (42 U .S.C.
263a) and 42 CFR 493, using FDA licensed tests including:
• HBsAg Hepatitis B Surface Antigen
• HBc-IgM/IgG Hepatitis B Total Core Antibody
• HCV Hepatitis C Antibody
• HIV 1/2-Ab Antibody to Human Immunodeficiency Virus Types I and 2
• RPR/STS or Equivalent Syphilis Detection
In addition to the above tests, donors recovered prior to March 9, 2005, were tested for HIV-I by p24 antigen testing or DNA Polymerase Chain Reaction (PCR) or Transcription
Mediated Amplification (TMA) Nucleic Acid Amplification Testing (NAT). Donors recovered after March 9, 2005, were tested using Human Immunodeficiency Virus Type I/
Nucleic Acid Amplification Testing (HIVI NAT) and Hepatitis C Virus/Nucleic Acid Amplification Testing (HCV NAT). Donors may or may not be tested for HTLV I/II (Human
T-Lymphotropic Virus Types I and II).
The results of all the relevant communicable disease tests referenced above were found to be negative. The communicable disease test results, together with the informed
consent, medical history interview, physical assessment, available medical records (to include previous medical history, laboratory test results, autopsy and coroner reports,
if performed), and information obtained from any source or records which may pertain to donor eligibility, have been evaluated. Based on this evaluation, the donor was
determined to meet donor eligibility criteria current at the time of recovery. The donor eligibility criteria used to screen this donor are in compliance with FDA regulations
published in 21 CFR Part 1270 “Human Tissue Intended for Transplantation” and/or Part 1271 “Human Cells, Tissues, and Cellular and Tissue-Based Products,” as applicable.
Donor eligibility was determined by one of the following tissue banks:
American Tissue Services Foundation,
Edmond, OK 73013
Musculoskeletal Transplant Foundation,
Edison, NJ 08837
Community Tissue Services,
Dayton, OH 45402
LifeNet Health,
Virginia Beach, VA 23453
RTI Biologics
Alachua, FL 32615
The names and addresses of the testing laboratories, the listing and interpretation of all required communicable disease tests, a listing of the documents reviewed as part of the
relevant medical records, and the name of the person or establishment determining the eligibility of this human tissue are on file at Medtronic and are available upon request.
The final tissue allograft product was released by Medtronic for transplantation, based on the initial donor eligibility determination and on a post-processing review and
determination that the product met all processing requirements and specifications.
VIRAL INACTIVATION
In the production of PLEXUR M® , the allograft bone is subjected to processing steps that have been shown to inactivate viruses, including HIV, hepatitis Band C and CMV.
of tissues in accordance with current FDA regulations and standards established by the American Association of Tissue Banks. The donor’s medical/social history was also
screened for HIV, Hepatitis and CJD/vCJD high risk factors in accordance with current United States Public Health Services Recommendations and FDA Federal Regulations
and Guidance Documents.
Testing of donor blood and tissue samples began at the site of recovery and continued into processing. Donor blood samples taken at the time of recovery were tested for
communicable disease by a laboratory certified to perform such testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (42 U .S.C.
263a) and 42 CFR 493, using FDA licensed tests including:
• HBsAg Hepatitis B Surface Antigen
• HBc-IgM/IgG Hepatitis B Total Core Antibody
• HCV Hepatitis C Antibody
• HIV 1/2-Ab Antibody to Human Immunodeficiency Virus Types I and 2
• RPR/STS or Equivalent Syphilis Detection
In addition to the above tests, donors recovered prior to March 9, 2005, were tested for HIV-I by p24 antigen testing or DNA Polymerase Chain Reaction (PCR) or Transcription
Mediated Amplification (TMA) Nucleic Acid Amplification Testing (NAT). Donors recovered after March 9, 2005, were tested using Human Immunodeficiency Virus Type I/
Nucleic Acid Amplification Testing (HIVI NAT) and Hepatitis C Virus/Nucleic Acid Amplification Testing (HCV NAT). Donors may or may not be tested for HTLV I/II (Human
T-Lymphotropic Virus Types I and II).
The results of all the relevant communicable disease tests referenced above were found to be negative. The communicable disease test results, together with the informed
consent, medical history interview, physical assessment, available medical records (to include previous medical history, laboratory test results, autopsy and coroner reports,
if performed), and information obtained from any source or records which may pertain to donor eligibility, have been evaluated. Based on this evaluation, the donor was
determined to meet donor eligibility criteria current at the time of recovery. The donor eligibility criteria used to screen this donor are in compliance with FDA regulations
published in 21 CFR Part 1270 “Human Tissue Intended for Transplantation” and/or Part 1271 “Human Cells, Tissues, and Cellular and Tissue-Based Products,” as applicable.
Donor eligibility was determined by one of the following tissue banks:
American Tissue Services Foundation,
Edmond, OK 73013
Musculoskeletal Transplant Foundation,
Edison, NJ 08837
Community Tissue Services,
Dayton, OH 45402
LifeNet Health,
Virginia Beach, VA 23453
RTI Biologics
Alachua, FL 32615
The names and addresses of the testing laboratories, the listing and interpretation of all required communicable disease tests, a listing of the documents reviewed as part of the
relevant medical records, and the name of the person or establishment determining the eligibility of this human tissue are on file at Medtronic and are available upon request.
The final tissue allograft product was released by Medtronic for transplantation, based on the initial donor eligibility determination and on a post-processing review and
determination that the product met all processing requirements and specifications.
VIRAL INACTIVATION
In the production of PLEXUR M® , the allograft bone is subjected to processing steps that have been shown to inactivate viruses, including HIV, hepatitis Band C and CMV.
R
LOT
Use PLEXUR M® according to the following surgical technique:
Remove blood clots and debris from the surgical site using lavage and/or suction instruments. Prepare the site by compacting cancellous bone with a curette, elevator, or
similar instrument.
When using PLEXUR M® with autograft in the spine, the recommended ratio for PLEXUR M® to autograft is 1:1, based on the results of a preclinical study in an in vivo PLF spine
model in which the autograft was in contact with the vertebral processes and the PLEXUR M® was folded around the lateral, medial and posterior surfaces of the autograft.
Heat PLEXUR M® immediately prior to use in order to make it moldable for shaping and/or placement in the patient. Firmly pack PLEXUR M® into the surgical site while
moldable. Ensure that the entire treatment site is filled and is in direct contact with well vascularized tissue.
treatment site.
Heating
(Refer to instruction manual included with the PLEXUR M® Heater.)
a.
b.
: If PLEXUR M® is placed in the heater without the clear wrapper, it will stick to the PLEXUR M® Lid and PLEXUR M® Drape and
c.
d.
e.
PLEXUR M® from the clear wrapper. Retain the clear wrapper in the sterile field in the event that PLEXUR M® needs to be reheated. Note: PLEXUR M® must be
Heating
a.
b.
c.
d.
e.
PLEXUR M® from the foil pouch and from the heating sleeve/wrapper. Note: it is recommended not to reheat PLEXUR M® in a water
PLEXUR M® will remain moldable for minimum of two (2) minutes, after which it gradually hardens as it continues to cool (see chart below). After approximately fifteen (15)
minutes from the time it is
from the heat source, PLEXUR M® will cool to a temperature at which it is completely hard (temperature of the surrounding environment
may influence the rate of cooling). At body temperature, PLEXUR M® will be hardened.
Osteotech® & Design, Plexur Biocomposites® & Design and Plexur M® & Design are registered trademarks of Osteotech, Inc. Covered by one or more of U.S. Patent No. 5.676,
146 C2; 5,607, 269; 6,440,444;6,696,073; 7,291, 345; and foreign patents. Other U.S. and foreign patents pending.
©2013 Medtronic Sofamor Danek USA, Inc. All rights reserved.
TISSUE TRACKING
Federal (USA) regulations under 21 CFR 1271 establish requirements for tracking of human tissue products. In accordance with these regulations, the package label of each
PLEXUR M unit distributed by Medtronic bears a lot number and serial number that serve as a distinct identification code and are recorded in Medtronic’s distribution records
for purposes of tracking the tissue to the consignee or user/tissue transplant facility. The lot number and serial number should be recorded in the user/tissue transplant
facility’s records and in the tissue recipient’s medical record, along with the following information:
I. Description of Tissue
2. Lot Number (Donor ID)
3. Product Code
4. Expiration Date
5. Quantity Implanted
6. Antibiotics Used
7. Description of Procedure
8. Date and Time of Procedure
9. Surgeon Name
10. Any Other Pertinent Information
For European Economic Area audience only - These tissue tracking records shall be maintained for 30 years after clinical use. In case product traceability to recipient is at risk,
the customer shall secure the transfer of the records to another entity (preferably a Tissue Establishment or Organ Bank) in order to secure continued traceability. Medtronic
BV shall be informed of such a transfer of records.
HANDLING AND USE
PLEXUR M® is provided sterile and should be considered sterile unless the packaging has been opened or damaged. This product should not be resterilized. All product
heating and handling must occur in the sterile field. Strict adherence to aseptic practices must be followed during the surgical procedure to prevent product contamination.
Place PLEXUR M® in the heater a minimum of 7 minutes prior to use. PLEXUR M® must be kept in the clear wrapper and placed in the heater with the folded sides up.
Peel open the outer Tyvek pouch of the PLEXUR M® and pass the inner foil pouch into the sterile field. Open the inner pouch and remove the PLEXUR M® , but do not
remove it from its clear wrapper. Caution
become difficult to remove.
While within the clear wrapper, heat PLEXUR M® for a minimum of 7 minutes to get pliability.
Remove PLEXUR M® from the heater, being careful not to touch the hot surfaces of the heater. Caution: The heating surfaces can cause personal injury or damage to
surgical gloves if touched.
Remove
in clear wrapper before placing back into the heater.
Prepare a bath of sterile hot water, heated to a temperature of 95±2°C (~ 203°F), in the sterile field.
Peel open the outer Tyvek pouch of the PLEXUR M® and pass the inner foil pouch into the sterile field.
Using sterile technique, place the foil pouch, still sealed, in the water bath. Use sterile forceps or comparable means to keep the foil pouch submerged. Caution: Take
care not to puncture the foil pouch with the forceps.
After I5 minutes remove the foil pouch from the water bath.
Open the foil pouch and remove
bath to avoid getting water into PLEXUR M® .
Remove excess material from the site. Close the site using standard closure techniques. Discard any unused PLEXUR M® .
PLEXUR M® using the PLEXUR M® Heater
PLEXUR M® using a water bath
removed
Avoid overfilling the surgical site or excessively compressing the
R
LOT
REF
15°C
15°C to 30°C
STERILE R
MR
SN
STERILE A
model in which the autograft was in contact with the vertebral processes and the PLEXUR M® was folded around the lateral, medial and posterior surfaces of the autograft.
Heat PLEXUR M® immediately prior to use in order to make it moldable for shaping and/or placement in the patient. Firmly pack PLEXUR M® into the surgical site while
moldable. Ensure that the entire treatment site is filled and is in direct contact with well vascularized tissue. Avoid overfilling the surgical site or excessively compressing the
treatment site. Remove excess material from the site. Close the site using standard closure techniques. Discard any unused PLEXUR M® .
Heating PLEXUR M® using the PLEXUR M® Heater
(Refer to instruction manual included with the PLEXUR M® Heater.)
a. Place PLEXUR M® in the heater a minimum of 7 minutes prior to use. PLEXUR M® must be kept in the clear wrapper and placed in the heater with the folded sides up.
b. Peel open the outer Tyvek pouch of the PLEXUR M® and pass the inner foil pouch into the sterile field. Open the inner pouch and remove the PLEXUR M® , but do not
remove it from its clear wrapper. Caution: If PLEXUR M® is placed in the heater without the clear wrapper, it will stick to the PLEXUR M® Lid and PLEXUR M® Drape and
become difficult to remove.
c. While within the clear wrapper, heat PLEXUR M® for a minimum of 7 minutes to get pliability.
d. Remove PLEXUR M® from the heater, being careful not to touch the hot surfaces of the heater. Caution: The heating surfaces can cause personal injury or damage to
surgical gloves if touched.
e. Remove PLEXUR M® from the clear wrapper. Retain the clear wrapper in the sterile field in the event that PLEXUR M® needs to be reheated. Note: PLEXUR M® must be
in clear wrapper before placing back into the heater.
Heating PLEXUR M® using a water bath
a. Prepare a bath of sterile hot water, heated to a temperature of 95±2°C (~ 203°F), in the sterile field.
b. Peel open the outer Tyvek pouch of the PLEXUR M® and pass the inner foil pouch into the sterile field.
c. Using sterile technique, place the foil pouch, still sealed, in the water bath. Use sterile forceps or comparable means to keep the foil pouch submerged. Caution: Take
care not to puncture the foil pouch with the forceps.
d. After I5 minutes remove the foil pouch from the water bath.
e. Open the foil pouch and remove PLEXUR M® from the foil pouch and from the heating sleeve/wrapper. Note: it is recommended not to reheat PLEXUR M® in a water
bath to avoid getting water into PLEXUR M® .
PLEXUR M® will remain moldable for minimum of two (2) minutes, after which it gradually hardens as it continues to cool (see chart below). After approximately fifteen (15)
minutes from the time it is removed from the heat source, PLEXUR M® will cool to a temperature at which it is completely hard (temperature of the surrounding environment
may influence the rate of cooling). At body temperature, PLEXUR M® will be hardened.
(Times are approximated and determined by simulated use.)
R
If PLEXUR M® cools and hardens before it can be shaped into the desired form, it can be re-heated. It is recommended that the cumulative heating time (initial heating
plus reheating) not exceed 50 minutes.
a.
b.
c.
d.
PLEXUR M® from the heater, being careful not to touch the hot surfaces of the heater. Caution: The heating surfaces can cause personal injury or damage to
e.
The contents of this package are designed for single patient, single procedure only. D o not re-sterilize. Do not use after expiration date. This material is temperature sensitive.
Store between 15-30°C (59-86°F). It is the responsibility of the transplant facility or clinician to maintain the product in the appropriate recommended storage conditions
prior to transplant.
For any product returns to Medtronic, a Return Authorization Number is required from Medtronic prior to returning this product. Refer to Medtronic’s Return Policy.
For European Economic Area audience only - The customer shall notify serious adverse events (means any untoward occurrence associated with the procurement, testing,
processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating
conditions for patients or which might result in, or prolong, hospitalization or morbidity) or serious adverse reactions (means an unintended response, including a communicable
disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life-threatening, disabling, incapacitating or
which results in, or prolongs, hospitalization or morbidity) within 1 day to their local Medtronic representative.
Plexur M is MR Safe.
Plexur M is a nonconducting or a nonmagnetic item which poses no known hazards in all MR environments for magnetically induced displacement force and magnetically
induced torque. In addition, the Plexur M is not susceptible to heating due to RF (radio frequency) fields. As such, Plexur M can justifiably be labeled as MR-Safe per ASTM F2503.
If Plexur M® is used in connection with any device which is not MR Conditional, please be advised that this combination has not been tested in the MR environment and,
therefore, higher heating and possible injury to the patient may occur.
Osteotech® & Design, Plexur Biocomposites® & Design and Plexur M® & Design are registered trademarks of Osteotech, Inc. Covered by one or more of U.S. Patent No. 5.676,
Heating time (to soften) Heating time may vary a minimum of 7 minutes
Moldable time (after removal from the heater)
Hardening time (after removal from the heater) 10 – 15 minutes
e-Heating PLEXUR M®
To reheat in the PLEXUR M® Heater, first wipe off bodily fluids if present as the fluids may affect product handling characteristics.
Place PLEXUR M® back into the clear wrapper.
Heat PLEXUR M® for a minimum of 7 minutes to get desired pliability.
Remove
surgical gloves if touched.
Remove PLEXUR M® from the clear wrapper.
> 2 minutes
STORAGE
RETURNS
MRI INFORMATION
146 C2; 5,607, 269; 6,440,444;6,696,073; 7,291, 345; and foreign patents. Other U.S. and foreign patents pending.
©2013 Medtronic Sofamor Danek USA, Inc. All rights reserved.
R
only
LOT
REF
CAUTION: Federal law (USA) restricts these devices to sale by or on the order of a physician
Consult instructions for use
Do not reuse
Batch code
Manufacturer
Catalogue number
Use-by date
30°C
15°C
15°C to 30°C
Temperature limit
STERILE R
Sterilized using irradiation
Do not use if package is damaged
MR
MR safe
SN
Serial number
STERILE A
Sterilized using aseptic processing techniques
©2013 Medtronic Sofamor Danek USA, Inc. All rights reserved.
EXPLANATION OF SYMBOLS
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