Per -(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes, primary usage information of all components, patient details 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 records will be identified and reviewed.
|
Per -4023 final report.Additional information, including post primary and pre revision x-rays, operative notes, primary usage information of all components, patient details and an update on the patient post revision was requested in order to progress with the investigation of this event, however, not all information could be provided.The appropriate device details were provided and the relevant device manufacturing and sterilisation records have identified and reviewed.Review of these records revealed no deviation from process or non-conformity of product that would have caused or contributed to the adverse event.Infection is a known complication with any invasive surgery and thus this case is now considered closed.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.
|