On initial receipt of the reported event, the event description was reviewed and with the limited information available at that time, a decision was made to report the event.However it can now be concluded that the reported event does not meet the definition of a product complaint since the reported information did not allege any deficiency in the identity, quality, reliability, safety, effectiveness or performance of the device resulting in a malfunction or adverse consequence to the patient.Review of the x-ray imaging provided by the health care facility indicated that the device had not yet reached full extension capacity and the surgeon was advised that he could continue to extend the in situ device without the requirement for a revision.The event is therefore not reportable.
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