It was documented on the paper that the taylor spatial frame (tsf) (smith & nephew) was applied to 1 patient, one year after surgery, the patient showed poor consolidation of bone and failure of bone union at the docking site in the distal tibia.(non-union).Iliac bone transplantation performed on the extended bones and docking site of the distal tibia.
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H3, h6: the device, used for treatment, was not returned for evaluation.Therefore, a product analysis could not be performed at this time and the reported event could not be confirmed.A medical investigation was conducted and confirms this case reports that a 12 year old boy diagnosed with ewing¿s sarcom was treated with a reconstruction bone transport involving the external fixation of taylor spatial frame.One year after the procedure the patient showed poor consolidation of bone and failure of bone union at the docking site in the distal tibia.Per the article a iliac bone transplantation was performed on the extended bones and docking site of the distal tibia.Without the requested clinical information, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded.In addition, the physician referenced in the abstract provided an analysis of all of the attached images.Therefore, no further interpretation of the attached images are required.No further medical assessment is warranted at this time.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
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