InterGro® DBM products (InterGro DBM Putty, InterGro DBM
Paste and InterGro DBM Plus) contain human tissue (allograft bone) and
are intended for transplantation. The allograft bone has been
granulated, demineralized and provided in a lipid carrier. The lipid
carrier used in the manufacture of InterGro DBM products is extracted
from soybean. The InterGro DBM Plus products contain porous ceramic
granules that are a composite of highly resorbable calcium carbonate
with a slower resorbing 2 μm to 10 μm outer layer of calcium phosphate.
Indications for Use
InterGro DBM products are to be used for filling bony voids or gaps
in the extremities and pelvis that are not intrinsic to the bony
stability of the structure, and as an autograft extender in the spine.
InterGro Plus may also be used as a bone void filler in the spine
(posterolateral spine). These defects may be surgically created
osseous defects or osseous defects created from traumatic injury to
bone. InterGro DBM may also be used for filling craniofacial defects
and craniotomies that are no larger than 25cm2. The amount
of InterGro DBM products to be used should be based on the type of
procedure and size of the graft site.
InterGro DBM products are contraindicated in patients with
incomplete skull growth.
InterGro DBM products are contraindicated if active or latent
infection is observed in or surrounding the implantation site.
Warnings and Precautions
InterGro DBM products are aseptically processed and remain aseptic
during the stated shelf-life in an unopened and undamaged package. The
product must be used before the expiration date. InterGro DBM must not
be used under any of the following conditions:
- If any of the package or product elements appear to be
missing, tampered with or damaged;
- If the product label or
identifying bar code is severely damaged, illegible, or
- If the expiration date shown on the package label
Do not subject InterGro DBM products or their packaging to
disinfection or sterilization procedures. InterGro DBM is intended for
single patient use only. To prevent cross-infection of graft
recipients and graft contamination, do not use the contents on
multiple patients. Empty or partially used containers should be
disposed of in accordance with recognized procedures for discarding
medical waste materials.
The production of all InterGro DBM products is performed in
environmentally controlled conditions and under rigorous quality
controls. The DBM component is processed with 50 units/mL Bacitracin,
500 units/mL Polymyxin B, Isopropyl Alcohol, Hydrochloric Acid, Sodium
Phosphate Buffer, Hydrogen Peroxide and Allowash® solution,
and may contain traces of these processing agents.
InterGro DBM products must be appropriately placed and/or fixed
according to the clinical requirements for the specific procedure to
avoid potentially adverse effects.
Closed suction or drainage is recommended to prevent wound fluid
accumulation when using InterGro DBM products.
InterGro DBM products may extrude into facial soft tissues and the
effect of extrusion in cranial applications, due to lack of soft
tissue, has not been investigated.
Use of InterGro DBM may result in loss of contour.
The use of InterGro DBM in a closed cavity may result in possible
pressurization of the cavity which could produce fat embolization or
embolization of device into the blood stream.
When used to fill craniofacial defects with minimal tissue coverage,
care should be taken to avoid overfilling the defect site with
InterGro. Excessive pressure or tension on the overlying tissue by an
overfilled defect could cause the wound to re-open. In addition, the
use of InterGro should be limited to craniofacial defects 25 cm² and
smaller which are characterized by pronounced bony margins that can
effectively contain the product at the site.
Patient smoking may result in delayed healing, non-healing, and/or
compromised stability in or around the placement site.
Read the instructions prior to use.
Extensive donor blood testing, medical and social history screening
procedures, and tissue microbiological testing have been used in the
qualification of all tissue donors. Despite the extensive tissue donor
selection and qualification processes used in providing this tissue
graft, transmission of infectious diseases through the use of this
tissue graft is still possible. Infection at the graft site may also
occur. Any adverse outcomes potentially attributable to InterGro DBM
products must be reported promptly to Biomet Osteobiologics at
303-443-7500. In the European Union (EU), reporting of serious adverse
reactions and/or events shall be in accordance with articles 5 and 6
of 2006/86/EU (2006/86/EU, annex II.E.), to the Tissue Establishment
indicated on the package label. InterGro DBM distributed in the EU
complies with the European Directive 2004/23/EC.
Product is for single use only. Re-use may result in product
contamination, patient infection, and/or failure of the device to
perform as intended.