Product Description
PlatFORM™ CM Blocks and PlatFORM™ CM Strips are collagen mineral
composite matrices processed into either a block or strip form for
surgical implantation. The principle components of PlatFORM™ CM Blocks
and Strips are bovine type I collagen and anorganic bovine bone
mineral. The mineral particles are dispersed within collagen fibers
forming a three-dimensional open porous matrix consisting of 80% bone
mineral and 20% collagen. PlatFORM™ CM Blocks and Strips are provided
as a sterile, dry material that is hydrated with autogenous bone
marrow at the point of use. PlatFORM™ CM Blocks and Strips are fully
resorbed during the natural process of bone formation and remodeling.
PlatFORM™ CM Pads and PlatFORM™ Putty are collagen mineral composite
matrices processed into pads or granular form for surgical
implantation. The principle components of PlatFORM™ CM Pads and Putty
are bovine type I collagen and anorganic bovine bone mineral. The
mineral particles are dispersed within collagen fibers forming a
three-dimensional open porous matrix consisting of 55% bone mineral
and 45% collagen. PlatFORM™ CM Pads and Putty are provided as a
sterile, dry material that is hydrated with autogenous bone marrow at
the point of use. PlatFORM™ CM Pads can be cut into shapes and are
designed to retain their shape and physical integrity following
implantation into a bony site, while PlatFORM™ CM Putty can be molded
to fit the bone defect. PlatFORM™ CM Pads and Putty are fully resorbed
during the natural process of bone formation and remodeling.
Indications
PlatFORM™ CM Blocks and Strips, combined with autogenous bone
marrow, is intended for use in filling bony voids or gaps of the
skeletal system (i.e., the extremities, spine and pelvis) that are not
intrinsic to the stability of the bony structure. These defects may be
surgically created osseous defects or osseous defects resulting from
traumatic injury to the bone.
PlatFORM™ CM Pads and Putty, combined with autogenous bone marrow,
are intended for use in filling bony voids or gaps of the skeletal
system (i.e., the extremities, spine and pelvis) that are not
intrinsic to the stability of the bony structure. These defects may be
surgically created osseous defects or osseous defects resulting from
traumatic injury to the bone.
Contraindications
PlatFORM™ CM Blocks and Strips must not be used in patients with
osteomyelitis at the operative site.
PlatFORM™ CM Blocks and Strips must not be used in patients with a
history of anaphylaxis, history of multiple allergies, known allergies
to bovine collagen, or who are being treated for desensitization to
meat products because this product contains bovine collagen.
PlatFORM™ CM Pads and Putty must not be used in patients with
osteomyelitis at the operative site.
PlatFORM™ CM Pads and Putty must not be used in patients with a
history of anaphylaxis, history of multiple allergies, known allergies
to bovine collagen, or who are being treated for desensitization to
meat products because this product contains bovine collagen.
Warnings
PlatFORM™ CM Blocks and Strips should not be used in fractures of
the growth plate, segmental defects, direct contact with the articular
space, and open fractures.
PlatFORM™ CM Pads and Putty should not be used in fractures of the
growth plate, segmental defects, direct contact with the articular
space, and open fractures.
Precautions
Caution should be exercised when treating individuals with bleeding
diatheses of any etiology.
PlatFORM™ CM Blocks and Strips should not be used to treat large
defects that in the surgeon’s opinion would fail to heal
spontaneously. PlatFORM™ CM Blocks and Strips must be used with
internal or external fixation as indicated or required.
Use of Nonsteriodal Anti-inflammatory (NSAIDs) medications may delay
graft healing. Use of alternate means of pain control should be
considered whenever possible. Abstinence from smoking during and after
treatment is highly advised.
If there is any evidence of compromised sterility (e.g., torn
packaging), the device must not be used.
PlatFORM™ CM Blocks and Strips cannot be re-sterilized. Open, unused
product must be discarded. In vivo stability may be adversely affected
if re-sterilized. Cross-contamination and infection may occur if re-used.
Caution should be exercised when treating individuals with bleeding
diatheses of any etiology.
PlatFORM™ CM Pads and Putty should not be used to treat large
defects that in the surgeon’s opinion would fail to heal
spontaneously. PlatFORM™ CM Pads and Putty must be used with internal
or external fixation as indicated or required.
Use of Nonsteriodal Anti-inflammatory (NSAIDs) medications may delay
graft healing. Use of alternate means of pain control should be
considered whenever possible. Abstinence from smoking during and after
treatment is highly advised.
If there is any evidence of compromised sterility (e.g., torn
packaging), the device must not be used.
PlatFORM™ CM Pads and Putty cannot be re-sterilized. Open, unused
product must be discarded. In vivo stability may be adversely affected
if re-sterilized. Cross-contamination and infection may occur if re-used.
Adverse Effects
The complications and inherent risks associated with bone grafting
surgery are not anticipated to increase with the use of PlatFORM™ CM
Blocks and Strips and PlatFORM™ CM Pads and Putty. Potential
complications of surgery include wound infection, reaction to
medications or anesthesia, pain, thromboembolism, cardiac or pulmonary
complications and blood loss. Potential postoperative risks include,
but are not limited to hematoma, urinary retention, thombophlebitis,
and continued pain. Also, all patients will be exposed to the same
risks associated with any bone grafting procedure such as fracture,
migration, resorption or rejection of the graft, delayed union,
nonunion, or pseudoathrosis. These complications may require
regrafting or revision. In addition, in some instances PlatFORM™ CM
Blocks and Strips and PlatFORM™ CM Pads and Putty may need to be
removed from the body, thus creating the need for a second surgery.
The possibility exists also for failure of the implant due to
incorrect surgical technique, patient noncompliance during
postoperative rehabilitation, and other unforeseen problems. A small
number of patients may experience localized immunological reactions to
this device that generally consist of transient localized edema,
swelling and rash. Although there is no evidence that the device will
be unsafe or ineffective in such patients, the safety and
effectiveness of the device in these patients has not been established.
PlatFORM™ CM Blocks and Strips and PlatFORM™ CM Pads and Putty have
not been used in clinical studies to treat patients with metabolic
bone disease, significant vascular disorders or clotting disorders,
uncontrolled diabetes, ankylosing spondylitis, achondroplasia, or in
patients undergoing anticoagulation therapy, immunosuppressive
therapy, or steroid therapy. No clinical data exists for use of
PlatFORM™ CM Blocks or Strips PlatFORM™ CM Pads or Putty in children
or pregnant women.