After The Surgical Procedure - KLS Martin group L1 Rib Gebrauchsanweisung

L1 Rib
Instructions for Use
4.4

After the surgical procedure

Possible risk of injury to the patient due to improper behavior by the patient!
Improper postoperative behavior of the patient can lead to implant failure or injuries of the patient. Note
the following:
• All physical activities that may adversely affect the implant or connected bone elements should be
avoided during the healing period. This applies especially to the carrying of heavy loads (danger of
falling) and to sporting activities that may involve impacts or blows.
• The surgeon must advise the patient on post-surgical procedure and carry out follow-up.
Possible risk of injury of the patient caused by burns or unintentional movement of the implant as well
as potential misinterpretation of examination results following MRI!
Due to the continuous development and increasing energy density of MRI devices, a negative effect on the
implants and patients cannot be ruled out for the future.
In case of doubt, MRI examination is not allowed before damage to the health of the patient has been
excluded.
Potential risks may involve heating or migration of implants possibly in response to the magnetic field.
Metal implants can furthermore cause disturbing artifacts in computer tomography (CT) as well as in
magnet resonance imaging (MRI).
The use of the implant must be documented in the patient file by entering the item designation as well as
REF and LOT. Only this way can clear traceability be ensured.
Removal of the L1 Rib implants (plates and screws) may be possible after bone healing. Metallic implants
can loosen, fracture, corrode, migrate, cause pain or stress shielding to the bone even after a fracture has
healed, particularly in young active patients. A titanium plate that is intended to assist the healing of bone
becomes a non-functional implant once this role is complete. It may then be regarded as a foreign body.
While there is no clear evidence to date that a titanium plate causes any actual harm, our knowledge
remains incomplete. It is therefore not possible to state with certainty that an otherwise asymptomatic
titanium plate left in situ in the long term is harmless. The removal of a non-functional titanium plate is
desirable provided the procedure to remove the plate does not cause any undue risk to the patient.
Implant removal should be followed by adequate postoperative management to avoid a fracture.
Revision 01 49