H6: the device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms without clinically relevant documentation, the root cause for the reported broken/malfunctioning legion hinges and the patient¿s subsequent revisions cannot be fully evaluated.The patient impact beyond the revisions and the postoperative healing, cannot be determined.No further medical assessment is warranted at this time.Should additional clinically relevant documentation/ information become available, the clinical/medical task may be re-evaluated.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique or implant failure.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
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