Reported via phone and e-mail; the (b)(6) hospital in (b)(6) and dr.(b)(6), who operates there, reported via the distributor, (b)(4), that the hospital is experiencing 'an infection problem' and 'having issues with their sterilization and validation process'.Of ten patients reported to have shown large wound infections, possibly caused by a pseudomona bacteria, this report is for one of those patients.This patient is reported to have had a large infection at the surgical wound site, with one revision surgery to remove the calix implant and infectious matter from around the implant site.This patient was treated with unspecified antibiotics before and after the revision at an unspecified dosage.It is estimated that the length of stay at the hospital has been approximately one to two weeks, but the exact dates were not given.This patient was also reported to be over eighty years old, weak due to the revision surgery and blood loss, and may have pneumonia.
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Additional information: it was reported that by (b)(6) 2015, the last patient had left the hospital.No new cases of infection associated with the calix tlif system have been reported from the hospital in leer via surgico.The complete consignment warehouse of calix surgical trays, and additional fortex surgical trays, were received by the manufacturer, x-spine systems, the devices were not available for investigation until 10/30/2015.No explanted calix implants were returned for evaluation by the complainant or received by the manufacturer x-spine.Within the returned g23 fortex surgical tray 6 pedical screws were found to have possible signs of use upon evaluation.
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