The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.
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The manufacturer became aware of a post market clinical follow-up report received from (b)(6) hospital, in usa.The title of this report is ¿a retrospective data collection of the treatment of the ankle with the t2 ankle arthrodesis nailing system¿ which is associated with the stryker ¿t2 ankle arthrodesis nailing¿ system.This report includes research done on 127 patients between the period april, 2019 and january, 2020.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses calcaneal screw backout and cause prominence followed by interlocking screw removal.The report states: ¿(b)(6) year old male with diabetes, neuropathy, charcot, obesity, pulmonary hypertension, copd, and cardiomyopathy underwent a ttc for charcot neuroarthropathy.He was initially lost to follow up but per reports between 200 and 300 days postoperatively had a calcaneal screw back out and cause prominence.Underwent interlocking screw removal at local hospital at an unknown date.He resumed his follow up 319 days after surgery at which point in time it was deemed he had achieved radiographic and clinical union.¿.
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