The device was reported to be an unknown xia 3 screw.No catalog or lot number were provided by the reporting hospital and the device was discarded.Neither a review of complaint history or device history records could not be performed without a valid lot number.Visual, dimensional, material, and functional analyses could not be performed because the device was not returned.It was reported that the decompression and fixation were performed using xia 3 for lcs on (b)(6) 2018.The implant was removed on (b)(6) 2018 due to infection.It was reported this patient later expired.Information regarding the type or cause of the infection was requested but not provided.According to the ifu: infection: transient bacteremia can occur in daily life.Dental manipulation, endoscopic examination and other minor surgical procedures have been associated with transient bacteremia.To help prevent infection at the implant site, it is advisable to use antibiotic prophylaxis before and after such procedures adverse effects: serious complications may be associated with any spinal surgery.These complications include, but are not limited to: genitourinary disorders; gastrointestinal disorders; vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; bursitis, hemorrhage, myocardial infarction, infection, paralysis or death.For safety reasons, non-sterile devices must be pre-cleaned, cleaned and sterilized prior to use.Moreover, for good maintenance, reusable instruments must be pre-cleaned, cleaned and sterilized immediately after surgery following the sequence of steps described in the following chart.It was reported that the patient expired due to an infection.It is unknown if the device contributed to the event and it there is no information provided that indicates that the device was caused or contributed to this event.Multiple follow-up attempts with the reporting hospital were performed and limited information was provided.If additional information becomes available in the future, that information will be provided in a supplemental report.
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