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
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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
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Nerve damage due to surgical trauma
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Vascular changes
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Hematomas and slow wound healing
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Periarticular calcification
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Reduced joint function and mobility
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Reduced joint load-bearing capacity; joint pain
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Allergic response or sensitivity to the implant material
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Increased reaction of the soft tissue around the osteotomy and/or the distraction system
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Growth restriction
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Pain, discomfort, anomalous sensations caused by the implant; implant palpability
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Poor healing
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Tissue discoloration due to contact with the implant material
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Insufficient ossification or delayed bone healing, osteoporosis, osteolysis, osteomyelitis,
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slow revascularization, infections or bone necroses, may cause the distraction system to
loosen, crack, fracture or become bent.
Inadequately high forces or weight loads may lead to wear, fracture, deformation,
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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
adequate postoperative care even after removal of the distraction system.
Fragments and microscopically small particles may come off the distraction system,
•
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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Instructions for Use
Rotterdam Palatal Distractor
V. 2.1