(b)(4).Additional information, including device details, post primary and pre revision x-rays, operative notes, patient medical history and the explanted devices has been requested in order to progress with this investigation, and if received, will be provided in a supplemental report upon completion of the investigation.Upon receipt of the appropriate device details the relevant device manufacturing records will be identified and reviewed.
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(b)(4) final report.Additional information, including device details, post primary and pre revision x-rays, operative notes, patient medical history and the explanted devices were requested in order to progress with the investigation of this event.However, this information was not provided and thus there was only very limited information available for the investigation.The device details were not provided and thus the device manufacturing records could not be identified or reviewed.Based on the information provided, no further investigation can be conducted and thus corin now consider this case closed.However, should additional information be provided then this case may be re-opened for further investigation.
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