Plexur P™ M708348B350E Rev. D
2017-03-09
IMPORTANT INFORMATION ON PLEXUR P™
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, SINGLE PROCEDURE ONLY
CAUTION: RESTRICTED TO USE BY A PHYSICIAN, PODIATRIST OR DENTIST
NO ADDITIONAL STERILIZATION STEP IS TO BE PERFORMED BY THE USER
DESCRIPTION (BRIEF DEVICE DESCRIPTION)
Plexur P™ is manufactured using a blend of resorbable polymers and bone fibers. This product is supplied sterile for single
patient use. Plexur P™ is provided as granules and in solid forms as blocks, wedges, sheets, and cylindrical plugs in a variety of
sizes. 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), cleaned using 70% alcohol, washed with purified water, and sonicated prior to combining it with
resorbable polymers to form the final product. 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 starting
bioburden. Each Plexur P™ final product lot was tested for endotoxins using a qualified test method. Plexur P™ is packaged in
ready-to-use form in single patient use containers. The lot number (for donor ID), expiration date, product code, quantity
(volume or size), and additional information are listed on the package label.
INDICATIONS
Plexur P™ is intended for use in filling bony voids or gaps of the skeletal system (i.e. spine, pelvis and extremities) 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. Plexur P™ may also be used as a bone graft extender in the spine. Plexur P™ is
resorbed/remodeled and is replaced by host bone during the healing process.
CONTRAINDICATIONS
Plexur P™ is not intended to provide structural support during the healing process; therefore, Plexur P™ is contraindicated
where the product is intended as structural support in the skeletal system.
Conditional representing relative contraindications include:
▪ 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 including hematoma, site drainage, infection, bone fracture and other complications that are possible
with any surgery.
▪ Fracture or extrusion of Plexur P™ 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.
WARNINGS AND PRECAUTIONS
As with any surgical procedure, care should be exercised in treating individuals with preexisiting 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.
Adequate fixation should be used to stabilize the implant site during bone 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 P™ must be reported promptly to Medtronic.
Do not use this product if packaging has been opened or damaged.
Strict adherence to proper sterile surgical technique is required when combining with autogenous blood and/or sterile fluids.
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 US 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 registered with the FDA to perform donor
testing and certified to perform such testing on human specimens under the Clinical Laboratory Improvement Amendments of
1988 (CLIA) (42 U.S.C. 263a) and 42 CFR Part 493 using FDA approved, licensed, or cleared tests including, but not limited to:
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 1 and 2
RPR/STS or Equivalent Syphilis Detection
HIV 1 NAT Human immunodeficiency virus type 1 nucleic acid amplification testing
HCV NAT Hepatitis C virus nucleic acid amplification testing
The results of all the relevant communicable disease tests referenced above were found to be negative or non-reactive.
In addition to the tests listed above, other tests may have been performed including, but not necessarily limited to, tests for HBV
NAT (Hepatitis B virus nucleic acid amplification testing) and WNV NAT (West Nile Virus nucleic acid amplification testing). If
HBV NAT and WNV NAT tests were performed, the results of these tests were negative or non-reactive, and the results of any
other tests performed were negative or otherwise acceptable for eligibility of donors of musculoskeletal tissues.
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
Surprise, AZ 85378
Community Tissue Services
Dayton, OH 45402
LifeNet Health
Virginia Beach, VA 23453
RTI Surgical, Inc.
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 based on the initial donor eligibility determination and on a postprocessing review and determination that the product met all processing requirements and specifications. This tissue allograft
product has been released for transplantation.
VIRAL INACTIVATION
In the production of Plexur P™, 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 P™ unit distributed by Medtronic bears a lot number that serves as a
distinct identification code and that is recorded in Medtronic’s distribution records for purposes of tracking the tissue to the
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