Indications, Safety, and Warnings AUTOGRAFT HARVESTING

Indications, Safety, and Warnings by Product


Corex Bone Harvester

INTENDED USE

The Corex™ Bone Harvester (Corex) is a supplied sterile, single patient use, manually operated trephine intended for harvesting cancellous bone from various skeletal sites.

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

Warning: Device is a single patient use item, reuse may result in failure of proper actuation and or biologic contamination. These consequences could result in adverse patient effects.

Warning: Osteopenic/Osteoporotic patients may have insufficient density of bone to facilitate use of the Corex ™ Bone Harvester. This device has sharp cutting surfaces and potentially represents a hazard to the user, patient, and disposer. All appropriate cautious handling should be exercised.

PRECAUTIONS

Once the trocar tip is removed, Corex’s trephine (hollow tube section) is not intended to further penetrate cortical bone. There are circumstances of use when cortical penetration might occur, or is even likely to occur. The surgeon must be keenly aware of this potential hazard, as serious or life-threatening injuries to nerves, vessels, or other soft tissue structures external to the bone’s cortical margins may result. The surgeon should understand the orientation and depth of penetration associated with the Corex cutting tip, relative to the skeletal anatomy within which it is being applied. Every effort to ensure that the cutting tip remains within the cancellous portion of the bone should be exercised. If there is any doubt, the device’s depth of entry and axial orientation should be measured and noted and, if appropriate, the device should immediately be withdrawn from the bone entry site.

Warning: Extreme caution should be utilized when placing the sharp tip of the device near vulnerable, “at risk” structures.

Warning: BE MINDFULL OF PENETRATION DEPTH WHEN DIRECTING HARVESTER TOWARD SCIATIC NOTCH. THE DISTAL ASPECT OF THE SECOND APPETURE IS 5CM FROM THE TIP OF THE TREPHINE.

ANTERIOR APPROACH
[SUGGESTED SIZE- 7MM] 300-070 and 300-07C

 

  • Stay between the inner & outer tables of the ASIS (Anterior Superior Iliac Spinous Process) as you direct the harvester under the rim of the Iliac crest.

 

 

MARROW CELLUTION BONE MARROW ASPIRATION NEEDLE

Sterile: Contents sterile unless package is opened, damaged, or expired. Do Not Re-sterilize.

INDICATIONS FOR USE

The Marrow Cellution Bone Marrow Aspiration Needle is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.

CONTRAINDICATIONS

Use only for bone marrow or autologous blood aspiration as determined by a licensed physician. The device is intended to be used by a physician familiar with the possible side effects, typical findings, limitations, indications and contraindications of bone marrow aspiration. The procedure should be performed on patients that are suitable for such procedure only.

CAUTION: For single patient use only. The design of this device may not perform as intended by the manufacturer if it is re-used. The manufacturer cannot guarantee the performance, safety and reliability of a reprocessed device. After use, this product may be a potential biohazard. Handle in a manner, which will prevent accidental puncture. Dispose of in accordance with applicable laws and regulations. Carefully place the used needle in a sharps biohazard container after the procedure is completed.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

Rx Only         Not Made With Natural Rubber Latex

Manufactured by Ranfac Corp.

30 Doherty Ave. Avon, MA 02322-0635

Tel: 1.800.2.RANFAC 1.508.588.4400

Email: info@ranfac.com MARROWCELLUTION.COM

Distributed by Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place Memphis, TN 38132

Tel: 1.901.396.3133

www.medtronic.com