The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use states: ¿post-operative patient activity: these implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time.For this reason post-operative instructions and warnings to patients are extremely important.External immobilization (e.G.Bracing or casting) may be employed until x-rays or other procedures confirm adequate bone consolidation.The implant is intended for temporary bone fixation.In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur, for example fracture or loosening of the implant or instability of the implant system.Regular post-operative examinations (e.G.X-ray checks) are advisable.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, one of the probable causes of failure could be patient factor such as incorrect behavior and high level of activity after the implantation.If device is returned or any further information is provided, the investigation report will be reassessed.
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