Neoligaments Infinity-Lock Button System Anwendung Seite 5

• The general principles of patient selection
and sound surgical judgement apply to the
reconstruction procedure. Do not use the device
for procedures which do not necessitate surgical
intervention, including Type I and II injuries.
• In revision cases where the recommended
position of the bone tunnel has been
compromised there is a risk that the more oblique
direction of the repair could cause the device to
fail.
• There is limited data on the use of the device for
chronic injuries and as such treatment of chronic
injuries should be based on professional user
judgement.
MRI Information
MR Conditional
Non-clinical testing demonstrated that the Infinity-Lock
Button System is MR conditional. A patient with this
device can be scanned safely in an MR system under
the following conditions:
• Static magnetic field of 1.5-Tesla and 3-Tesla, only.
• Maximum spatial gradient magnetic field of
4,000-Gauss/cm (40-T/m)
• Maximum MR system reported, whole body
averaged specific absorption rate (SAR) of 2-W/
kg for 15 minutes of scanning (i.e. per pulse
sequence) in the Normal Operating Mode.
Under the scan conditions defined, the Infinity-Lock
Button System is expected to produce a maximum
temperature rise of 1.5 °C after 15 minutes of
continuous scanning (i.e. per pulse sequence).
In non-clinical testing the image artefact caused by the
Infinity-Lock Button System extends approximately
15-mm from this implant when imaged using a gradient
echo pulse sequence and a 3-Tesla MR System.
Precautions
Packaging:
• The device is supplied pre-packaged and sterile.
• Inspect the device, packaging and labelling prior
to use and do not use if damaged. Contact Xiros if
the package has been opened or altered.
Handling and storage:
• No specific storage conditions are required other
than good warehousing practice.
• Avoid damage when handling the Tube-Tape.
Avoid crushing or crimping when using surgical
instruments such as forceps or needle holders.
• Use aseptic technique throughout the procedure.
Pre-operative:
• It is recommended that patients are placed
on prophylactic antibiotics prior to surgery, to
minimize the risk of latent infections developing at
the implant site.
Intra-operative:
• Care should be taken to avoid nerves and other
anatomical hazards during surgery, as well as
possible infection.
• Take care to round the upper edges of the bone
tunnel to prevent abrasion of the Tube-Tape.
• Ensure there is sufficient bone around the tunnel
in the clavicle to resist expected forces, taking
account of the quality of the bone.
• Check that the repair is physiological and does
not restrict range of motion.
• When trimming the Tube-Tape to length, cut
straight across at right angles to minimize the
generation of loose fibres and carefully remove
any created from the wound.
• When drilling the bone tunnel ensure the tape is
positioned away from the underside of the clavicle
to prevent accidental damage from the drill.
Post-operative
• Patients should be warned not to exceed
appropriate activity levels or to overload the repair
before complete healing has occurred.
Potential Adverse Effects
Below is a list of the potential adverse effects (e.g.,
complications) associated with the use of the device
including: 1) risks associated with any surgical
procedure; 2) risks associated with acromioclavicular
joint reduction; 3) risks associated with synthetic
implants for acromioclavicular joint reduction.
Additional surgery may be required to correct some of
these events.
1) Pertinent risks associated with any surgical
procedure include: Infection and pain.
2) Pertinent risks associated with acromioclavicular
joint reduction include: Loss of reduction; Lack of
reduction; Recurrence; Bone fracture; Impaired
wound healing; Ligament calcification/Ossification
and; Arthritis/Degenerative arthropathy.
3) Risks associated with synthetic implants for
acromioclavicular joint reduction, including the
Infinity-Lock Button System, include: Irritation;
Allergic and/or inflammatory tissue reactions;
Device failure and; Clavicular osteolysis/erosion.
As with any procedure of this type, there is a risk that
surgery may not be effective in treatment or may
cause worsening symptoms.