WS 2995-eIFU
R8.1/2019-03
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
[email protected] l www.ulrichmedical.com
11
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.
SYSTEM:
obeliscPRO™/obelisc™
COUNTRY:
USA
Rx only
BEFORE CLINICAL USE, TAKE NOTE OF THESE INSTRUCTIONS FOR USE AND
THE SYSTEM-RELATED SURGICAL TECHNIQUE!
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
MANUFACTURER:
DISTRIBUTED IN THE USA BY:
ulrich GmbH & Co. KG
ulrich medical
USA Inc.
Buchbrunnenweg 12
18221 Edison Avenue
89081 Ulm l Germany
Chesterfield, MO 63005 l USA
(636) 519-0268
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 [email protected].
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
Contraindications of this device are consistent with those of other spinal implants.
Instances in which the obelisc is contraindicated include, but are not limited to, those cases where the following conditions exist:
Patients with acute Infection
Patients with signs of local infection
Patients with fever or leukocytosis
Patients with obesity
Pregnancy
Patients with mental illness
Drug or alcohol abuse
Patients with suspected or documented metal allergy or intolerance
Any patient having inadequate tissue coverage over the operative site
Any patient unwilling to cooperate with the postoperative instructions
Patients with rapid joint disease, bone absorption, osteopenia and/or osteoporosis.
Osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction and the amount of mechanical
fixation.
Any case not described in the indications
Any other medical or surgical condition which would preclude the potential of spinal implant surgery
2019-09-10
