BioSet DBM Moldable
INDICATIONS
These products are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. These products are indicated to be packed into bony voids or gaps of the skeletal system (e.g. the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
CONTRAINDICATIONS
These products are contraindicated where stabilization of the defect is not possible.
WARNINGS
The same medical/surgical conditions or complications that apply to any surgical procedure may occur during or following implantation. The surgeon is responsible for informing the patient of the risks associated with their treatment and the possibility of complications or adverse reactions. As with any human tissue implant, the potential for transmission of infectious agents may exist.
Successful treatment is dependent upon the patient’s host tissue response. Resorption of the implant along with commensurate substitution of functional host tissue is required to restore function. Fragmentation, displacement and/or disintegration of the implant at the surgical site may compromise its integrity and/or function.
A small number of patients may experience localized immunological reactions to the implant and/or trace amounts of the following residual chemicals from the manufacturing process; ascorbic acid, hydrochloric acid, hydrogen peroxide, isopropyl alcohol, povidone-iodine, sodium hydroxide and sodium phosphate buffer. The reactions typically involve transient localized edema and swelling, or a rash. Although there is no evidence that the implant will be unsafe or ineffective in such patients, the safety and effectiveness in these patients has not been established.
To avoid collapse at the site of implantation, do not use in osseous defects that are intrinsic to the stability of the bony structure unless independent stabilization can be achieved.
Do not implant in patients who have known allergies to porcine collagen or who have been treated for desensitization to meat products.
PRECAUTIONS
Prior to use, the surgeon must become familiar with the implant and the surgical procedure.
BioSet DBM Flowable
INDICATIONS
These products are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. These products are indicated to be packed into bony voids or gaps of the skeletal system (e.g. the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
CONTRAINDICATIONS
These products are contraindicated where stabilization of the defect is not possible.
WARNINGS
The same medical/surgical conditions or complications that apply to any surgical procedure may occur during or following implantation. The surgeon is responsible for informing the patient of the risks associated with their treatment and the possibility of complications or adverse reactions. As with any human tissue implant, the potential for transmission of infectious agents may exist.
Successful treatment is dependent upon the patient’s host tissue response. Resorption of the implant along with commensurate substitution of functional host tissue is required to restore function. Fragmentation, displacement and/or disintegration of the implant at the surgical site may compromise its integrity and/or function.
A small number of patients may experience localized immunological reactions to the implant and/or trace amounts of the following residual chemicals from the manufacturing process; ascorbic acid, hydrochloric acid, hydrogen peroxide, isopropyl alcohol, povidone-iodine, sodium hydroxide and sodium phosphate buffer. The reactions typically involve transient localized edema and swelling, or a rash. Although there is no evidence that the implant will be unsafe or ineffective in such patients, the safety and effectiveness in these patients has not been established.
To avoid collapse at the site of implantation, do not use in osseous defects that are intrinsic to the stability of the bony structure unless independent stabilization can be achieved.
Do not implant in patients who have known allergies to porcine collagen or who have been treated for desensitization to meat products.
PRECAUTIONS
Prior to use, the surgeon must become familiar with the implant and the surgical procedure.
