B. Braun Aesculap Spine Quintex Gebrauchsanweisung/Technische Beschreibung Seite 2

®
Aesculap
Quintex® plates and screws
Intended use
The Quintex® cervical plating system is used for the anterior monosegmental and multisegmental stabilization of
the cervical spine. It consists of the following components:
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Bone plates
– Hybrid cervical plate
– Dynamic cervical plate
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Screws
– Constrained bone screw (10 mm to 22 mm, ∅ 4.0 mm)
– Semiconstrained bone screw (10 mm to 22 mm, ∅ 4.0 mm)
– Dynamic bone screw (10 mm to 22 mm, ∅ 4.0 mm)
– Constrained bone screw (11 mm to 19 mm, ∅ 4.5 mm)
– Semiconstrained bone screw (11 mm to 19 mm, ∅ 4.5 mm)
– Dynamic bone screw (11 mm to 19 mm, ∅ 4.5 mm)
Special instruments are required to implant these components.
Materials
The materials used in the implant are listed on the packaging:
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ISOTAN® titanium forged alloy Ti6Al4V acc. to ISO5832-3
F
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Phynox® cobalt alloy acc. to ISO 5832-7
The titanium implants are coated with a colored oxide. Slight changes in coloration may occur, but do not affect the
implant quality.
ISOTAN® is a registered trademark of Aesculap AG, 78532 Tuttlingen / Germany.
Phynox® is a registered trademark of Imphy S.A., Paris / France.
Indications
Surgical implants serve to support normal healing processes. They should neither replace normal structures of the
body nor bear loads on a permanent basis in the case of incomplete healing.
Use for:
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Degenerative disk disease (diskogenic pain with degeneration of the intervertebral disks confirmed by the
patient's anamnesis and radiographic studies)
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Trauma (including fractures or dislocations)
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Post-traumatic kyphosis or lordosis
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Tumors
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Spondylolisthesis
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Spinal stenosis
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Deformity (scoliosis, kyphosis, and/or lordosis)
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Pseudarthrosis following an unsuccessful spinal operation
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Symptomatic cervical spondylosis
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Instability following surgical intervention due to the indications listed above
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Reoperations necessitated by prior fusion failure
For these indications, screws can be fixated in the region C2 to T1.
Contraindications
Do not use in the presence of:
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Fever
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Acute or chronic vertebral infections of a local or systemic nature
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Pregnancy
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Severe osteoporosis or osteopenia
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Medical or surgical conditions that could negatively affect the outcome of the implantation
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Mental illness
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Dependency on pharmaceutical drugs, drug abuse, or alcoholism
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Adiposity
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Severely damaged bone structures that could prevent stable implantation of implant components
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Neuromuscular disorders or illnesses
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Bone tumors in the region of implant fixation
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Wound healing disorders
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Generally poor condition of the patient
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Inadequate patient compliance
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Foreign body sensitivity to the implant materials
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Systemic or metabolic diseases
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Anticipated overloading of the implant
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Patients who are or are suspected of being allergic to nickel may experience sensitivity, as the Phynox® material
does contain nickel
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Cases not listed under indications
Side effects and interactions
The application or improper use of this system entails the following risks:
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Implant failure resulting from excessive load
– Warping or bending
– Loosening
– Breakage
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Inadequate fixation
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Failed or delayed fusion
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Infection
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Fractured vertebral body or bodies
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Injuries to
– nerve roots
– spinal cord
– blood vessels
– organs
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Neurological complications due to overdistraction
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Loss of intervertebral disk height due to the removal of load-bearing bone material
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Pseudarthrosis
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Resorption of bone chips
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Spondylolisthesis
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Tissue reaction to the implant materials
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Bone atrophy or diminished bone density
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Reduced joint mobility and flexibility
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Limited physical ability and arthralgia
Safety notes
This system is not licensed to be screwed onto, or affixed to, the posterior ele-
ments (pedicles) of the cervical, thoracic, or lumbar spine.
WARNING
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It is the operating surgeon's responsibility to ensure that the surgical procedure is performed properly.
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General risk factors associated with surgical procedures are not described in this documentation.
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The operating surgeon must have a thorough command of both the hands-on and conceptual aspects of the
established operating techniques.
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The operating surgeon must be fully conversant with bone anatomy, including the pathways of nerves, blood ves-
sels, muscles, and tendons.
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It is the operating surgeon's responsibility to ensure the correct combination of implant components and their
implantation.
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Aesculap is not responsible for any complications arising from erroneous indication, wrong choice of implant,
incorrect combination of implant components and operating technique, the limitations of the treatment method,
or inadequate asepsis.
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The user instructions for individual Aesculap implant components must be followed.
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The implant components were tested and approved in combination with Aesculap components. If other combi-
nations are used, the responsibility for such action lies with the operating surgeon.
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Do not, under any circumstances, combine implant components from different manufacturers.
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Do not, under any circumstances, use damaged or surgically excised components.
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Implants that have been used before must not be reused.
The implant has not been evaluated for safety and compatibility in the MR envi-
ronment. It has not been tested for heating, migration or image artifact in the MR
environment. Scanning a patient who has this implant may result in patient injury.
WARNING
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Delayed healing can cause implant breakage due to metal fatigue.
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The physician in charge decides whether the implanted components should be removed again, taking the risks
associated with a further operation and the difficulty of interventions to remove implants into account.
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Damage to the load-bearing structures of the implant can lead to loosening of components, dislocation, migra-
tion, and other severe complications.
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The implant components applied, along with their article numbers, the name of the implant, as well as the batch
number and serial number (if available) must be documented in all patient records.
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Postoperatively, individual patient information, as well as mobility and muscle training, is of particular impor-
tance.
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In order to promote the earliest possible detection of any problems or complications, the operation results must
be followed up at regular intervals with the aid of appropriate examination procedures. A precise diagnosis
requires x-rays taken in the directions anterior-posterior and medial-lateral.
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The implant components used must be documented in the patient records, identified by their respective article
number and implant designation, as well as the batch number and serial number (if applicable).
Sterility
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The implant components are supplied in an unsterile condition.
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The implant components are packaged individually.
►
Store the implant components in their original packaging and only remove them from their original and protec-
tive packaging immediately prior to application.
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Use a suitable tray for cleaning/disinfection.
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Use the system storage device only for sterilization and sterile provision.
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Ensure that the implant components in their implant system storage devices do not come into contact with each
other or with instruments.
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Ensure that the implant components are not damaged in any way.
Prior to initial sterilization and subsequent resterilization, the implant components must be cleaned using the fol-
lowing validated reprocessing procedure:
Note
Adhere to national statutory regulations, national and international standards and directives, and local, clinical
hygiene instructions for sterile processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant
national regulations concerning the reprocessing of products.
Note
Successful processing of this medical device can only be ensured if the processing method is first validated. The oper-
ator/sterile processing technician is responsible for this.
The recommended chemistry was used for validation.
Note
If there is no final sterilization, then a virucidal disinfectant must be used.
Note
For up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at
https://extranet.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap sterile container system.