Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: mitek medical safety department discovered this published white paper detailing a historical event in which some mitek devices were implicated.It cannot be confirmed that this issue had been previously reported to mitek, so an adverse event report is being filed to document the experience described in the article.Additional information was requested from the author but none was provided due to privacy rules.At this point in time, no further action is warranted.However, this file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.Mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi - unavailable associated medwatch: 1221934-2017-10218.
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This report is being filed after the subsequent review of the following literature article: anterior glenoid rim fracture following use of resorbable devices for glenohumeral stabilization.Authors: augusti carlo alberto and ¿et al¿ the orthopaedic journal of sports medicine, 3(6), 2325967115586559 doi: 10.1177/2325967115586559 2015 palpaolo@tin.It uo chirurgia della spalla e gomito ospedale cervesi di cattolica, cattolica, italy n=1 (b)(6) male that experienced osteolysis around the anchors.
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