Usa - ulrich medical Obelisc Instructions For Use Manual

SYSTEM:
COUNTRY:
Rx only
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
MANUFACTURER:
ulrich GmbH & Co. KG
Buchbrunnenweg 12
89081 Ulm l Germany
Package Insert: IMPORTANT INFORMATION for Surgeons, Medical Staff and Patients on the Use of obelisc/obeliscPRO
FOR QUESTIONS OR FURTHER INFORMATION
For questions or further information or to obtain a copy of the obelisc Surgical Technique Manual, please contact ulrich medical USA, located at
18221 Edison Avenue, Chesterfield, MO 63005, or call (636) 519-0268 or send an email to spine@ulrichmedicalusa.com.
INDICATIONS/INTENDED USE
Vertebral body replacement intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed,
damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The obelisc is intended to be used with supplemental internal
spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e., posterior pedicle screw and rod systems, anterior
plate systems, and anterior screw and rod systems). The use of bone grafting material with the obelisc is optional.
CONTRAINDICATIONS
ƒ Contraindications of this device are consistent with those of other spinal implants.
ƒ Instances in which the obelisc is contraindicated include, but are not limited to, those cases where the following conditions exist:
ƒ Patients with acute Infection
ƒ Patients with signs of local infection
ƒ Patients with fever or leukocytosis
ƒ Patients with obesity
ƒ Pregnancy
ƒ Patients with mental illness
ƒ Drug or alcohol abuse
ƒ Patients with suspected or documented metal allergy or intolerance
ƒ Any patient having inadequate tissue coverage over the operative site
ƒ Any patient unwilling to cooperate with the postoperative instructions
ƒ Patients with rapid joint disease, bone absorption, osteopenia and/or osteoporosis.
ƒ Osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction and the amount of mechanical
fixation.
ƒ Any case not described in the indications
ƒ Any other medical or surgical condition which would preclude the potential of spinal implant surgery
This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU. The onus resides with
the user to ensure that the most up-to-date IFU is used.
ulrich GmbH & Co. KG l Buchbrunnenweg 12 l 89081 Ulm l Germany
Phone: +49 (0)731 9654-0 l Fax: +49 (0)731 9654-2705
spine@ulrichmedical.com l www.ulrichmedical.com
obeliscPRO™/obelisc™

USA

BEFORE CLINICAL USE, TAKE NOTE OF THESE INSTRUCTIONS FOR USE AND
THE SYSTEM-RELATED SURGICAL TECHNIQUE!
DISTRIBUTED IN THE USA BY:
ulrich medical USA Inc.
18221 Edison Avenue
Chesterfield, MO 63005 l USA
(636) 519-0268
11
WS 2995-eIFU
R8.1/2019-03
2019-09-10