(b)(4) initial report.Additional information, including post primary and pre revision x-rays, the explanted devices, operative notes and patient medical history 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.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.
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(b)(4) final report.Additional information, including post primary and pre revision x-rays, operative notes, patient age and activity level, patient medical history and the return of the explanted devices was requested in order to progress with this investigation, however, not all were provided and thus there was only very limited information available for the investigation.It was confirmed that the explanted devices were discarded by the hospital following the revision and therefore, could not be examined.The appropriate device details were provided and the relevant device manufacturing records were identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.Based on the information available for this event, no further investigation can be conducted and thus corin now consider this case closed.However, if additional information becomes available then this case may be re-opened for further investigation.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.
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