The implants remain in-situ.There are no plans for revision surgery.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.Based on the information provided, a root cause could not be determined.If additional information is received, a supplemental report will be filed accordingly.Labeling review: "warnings/cautions/precautions: potential risks identified with the use of this device, which may require additional surgery, include device component fracture, loss of fixation, non-union, fracture of the vertebrae, and necrosis of bone, neurological injury and vascular or visceral injury." possible adverse effects: the following complications and adverse reactions have been shown to occur with the use of similar spinal instrumentation.These effects and any other known by the surgeon should be discussed with the patient preoperatively.1.Loss of desired spinal curvature, spinal correction and/or a gain or loss in height.2.Initial or delayed loosening, disassembly, bending, dislocation and/or breakage of device components.".
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