There are multiple patients all information is provided in the article.This report is for an unknown sternal fixation/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.".
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This report is being filed after the review of the following journal article: haenen, f.W.N., smith, t., and daeter, e.(2019), let me out¿of the synthes fixation system, european journal of cardio-thoracic surgery, vol.55, page 1 (netherlands) this study presents a case report of a patient who had recurrent sternal pain after refixation with the synthes sternal fixation system, with upward migration of the emergency release pin to prevent migration and subsequent luxation of the titanium sternal fixation system.This report is for an unknown synthes sternal fixation system.A copy of the literature article is being submitted with this medwatch.This report is for 1 unknown sternal fixation.This is report 1 of 1 for (b)(4).
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