The devices were not returned for evaluation nor any infection documents (e.G.Laboratory test results) have been received.Thus, the reported event could not be confirmed.Further information has been requested regarding the reported event.No further details to the screws (i.E.Catalog numbers) could be provided.As described in the event description, the patient had inquired an infection 3 weeks post surgery and had been treated with antibiotics.However, as patient is non-compliant to post operative care instructions, surgeon had to perform revision surgery on (b)(6) 2020.Patient is reported to be doing well.Sales rep also stated that the surgeon does not know whether infection was due to non-compliance of the patient or the loosening of the device.Infection is a known adverse event related to this procedure.It has been documented in the instructions for use associated with this device that this type of adverse event may rather be clinically related than implant related.Based on statistical evaluation there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.Therefore, no further corrective and / or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.Should further information be available, the investigation will be re-evaluated.H3 other text : product not available for return.
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