WS 3895-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
7
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:
uCentum™ comprehensive posterior system
LANGUAGE:
English
The only version applicable to users in the U.S. is the version intended especially for the
United States.
Read all instructions carefully. Failure to follow instructions, warnings and precautionary measures
may have severe consequences or result in patient injury.
Take into careful consideration all product materials before clinical use.
The required product materials prepared as overall documentation of the system are: system related
instructions for use, surgical technique and, if applicable, supplements, assembly and disassembly
instructions, as well as "Processing manual implants and instruments" UH 1100.
1 Intended use
uCentum is an implant system for the posterior surgical stabilization, fixation and correction of the mature human thoracic and lumbar spine,
including the sacrum if necessary.
2 Product description
The uCentum system consists of pedicle screws, rods, crosslinks, offset connectors, pedicle hooks and lamina hooks. Pedicle screws may be
engineered as polyaxial, monoaxial, pre-fixation or longarm screws and are available in various diameters and lengths. All screw variants may
be used in free combinations and some with the same instruments. Moreover, pedicle screws are designed in cannulated or not cannulated
forms. Cannulated pedicle screws may be placed by means of a guidewire. Cannulated pedicle screws with a perforation on the tip of the screw
permit cement augmentation. uCentum rods have a diameter of 6.0 mm, are straight or pre-curved, and available in different lengths. Differ-
ent sizes of crosslinks, offset connectors and hooks may be used in order to achieve completion of the instrumentation process. The uCentum
system is to be used for bilateral instrumentation and may be applied using either an open or percutaneous approach.
3 Indications
The uCentum implant system is indicated for the following diseases:
Degenerative disc disease
Deformity
Spinal tumor
Spondylolisthesis
Failed prior fusion
Pseudoarthrosis
Spinal stenosis
Destruction
Instability
4 Contraindications
In the following cases an implantation of uCentum should not be performed:
Patients with fever or leukocytosis with non-spine associated infections
Patients with a history of metal allergy
Patients who tend to react to foreign bodies
5 Possible side effects
Possible complications associated with the implant are:
Implant loosening, dislocation and/or implant failure
Local or systemic reactions due to material intolerance
Failure of bony fusion
2019-05-06
