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. Use of InterGro DBM may
result in loss of contour.
Patient smoking may result in delayed healing, non-healing, and/or
compromised stability in or around the placement site.
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.