(b)(4) initial report: additional information including post primary and pre revision x-rays, operative notes and an update on the patient post revision has been requested in order to progress with the investigation of this event, 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 and sterilisation 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.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
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Per -5117 finall report: additional information, including post primary and pre revision x-rays, operative notes and an update on the patient post revision has been requested in order to progress with the investigation of this event , however this information could not be provided.The appropriate device details have been provided and the relevant device manufacturing records have been identified and reviewed.The finished parts were cleaned, packaged and sterilised to the correct specifications at the time of manufacture.The sterilization method and sterile barrier system used to package corin devices have a long history of safe and effective use at corin for a wide range of orthopaedic devices and has been validated in accordance with the relevant standards.Based on the above, no further investigation can be conducted and the root cause of the infection could not be determined.Therefore, this case is now considered closed.However, should any additional information be provided then this case may be reopened 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.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
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