Potential Side Effects And Complications - KLS Martin group Rotterdam Instrucciones De Uso

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Potential Side Effects and Complications

• Reduced bone density and / or bone necroses due to mechanical stress
• Vascular changes
Dislocations and partial dislocations
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Early and late infections, surface and / or deep infections
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• Nerve and vascular injuries
Hematomas and slow wound healing
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Periarticular calcification
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• Reduced joint function and mobility
Reduced joint load-bearing capacity; joint pain
•
Allergic response or sensitivity to the implant material
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• Nerve damage due to surgical trauma
Insufficient ossification or delayed bone healing, osteoporosis, osteolysis, osteomyelitis,
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slow revascularization, infections or bone necroses, all of which may cause the distraction
system to loosen, crack, fracture or become bent
• Inadequately high forces or weight loads may lead to wear, fracture, deformation,
loosening or migration of the distraction system.
After completion of the consolidation phase, distraction systems may come loose, corrode,
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dislocate or cause pain, especially in young, physically active patients.
To prevent fracture of the new bone tissue, it is important to provide the patient with
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adequate postoperative care even after removal of the distraction system.
Growth restriction
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Pain, discomfort, anomalous sensations caused by the implant; implant palpability
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• Increased reaction of the soft tissue around the osteotomy and / or the distraction system
Poor healing
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Tissue discoloration due to contact with the implant material
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Fragments and microscopically small particles may come off the distraction system,
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migrating away from the implantation site. These metal particles may remain in the
patient's body even after removing the implant. The long-term effects of such particles are
presently unknown.
Apart from the side effects described above, it should be noted that any surgical intervention
can lead to complications not necessarily caused by the distraction system (such as infections,
nerve injuries and pain).
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Rotterdam-Midline Distractor / Bologna-Midline Distractor
Instructions for Use
V. 3.0