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PKGI-70-H Effective 03-2019
mechanisms. Particular care should be paid to drivers, drill
bits and instruments used for cutting or implant insertion.
SURGICAL TECHNIQUES:
Surgical techniques are available
describing the uses of this system. It is the responsibility of the
surgeon to be familiar with the procedure before use of these
products. In addition, it is the responsibility of the surgeon to be
familiar with relevant publications and consult with experienced
associates regarding the procedure before use. Surgical
Techniques can be found on the Acumed website (acumed.net).
IMPLANT WARNINGS:
For safe effective use of the implant,
the surgeon must be thoroughly familiar with the implant, the
methods of application, instruments, and the recommended
surgical technique for the device. The device is not designed to
withstand the stress of weight bearing, load bearing, or excessive
activity. Improper insertion of the device during implantation can
increase the possibility of loosening or migration. The patient must
be cautioned, preferably in writing, about the use, limitations, and
possible adverse effects of this implant. These cautions include
the possibility of the device or treatment failing as a result of loose
fixation and/ or loosening, stress, excessive activity, or weight
bearing or load bearing, particularly if the implant experiences
increased loads due to delayed union, nonunion, or incomplete
healing, and the possibility of nerve or soft tissue damage related
to either surgical trauma or the presence of the implant. The
patient must be warned that failure to follow postoperative care
instructions can cause the implant and/ or treatment to fail. The
implants may cause distortion and/or block the view of anatomic
structures on radiographic images. The components of these
systems have not been tested for safety, heating, or migration in
the MRI environment. Similar products have been tested and
described in terms of how they may be safely used in post-
operative clinical evaluation using MRI equipment
1
.
1
Shellock, F. G. Reference Manual for Magnetic Resonance Safety, Implants, and
Devices: 2011 Edition. Biomedical Research Publishing Group, 2011.
SURGICAL INSTRUMENT WARNINGS:
For safe effective use
of any Acumed instrument, the surgeon must be familiar with the
instrument, the method of application, and the recommended
surgical technique. Instrument breakage or damage, as well as
tissue damage, can occur when an instrument is subjected to
excessive loads, excessive speeds, dense bone, improper use or
unintended use. The patient must be cautioned, preferably in
writing as to the risks associated with these types of instruments.
IMPLANT PRECAUTIONS:
An implant shall never be reused.
Previous stresses may have created imperfections, which can
lead to a device failure. Protect implants against scratching and
nicking. Such stress concentrations can lead to failure. Bending
plates multiple times may weaken the device and could lead to
premature implant fracture and failure.
Mixing implant
components from different manufacturers is not recommended for
metallurgical, mechanical and functional reasons. The benefits
from implant surgery may not meet the patient’s expectations or
may deteriorate with time, necessitating revision surgery to
replace the implant or to carry out alternative procedures.
Revision surgeries with implants are not uncommon.
English– EN/ PAGE 12
EN
Summary of Contents for ACU-LOC Series
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