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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown elite bone staple/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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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Event Description
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It was reported that the patient underwent ankle arthrodesis on an unknown date.Postoperatively, patient had a superficial infection that required for a return to or.Patient had a reoperation due to removal of all staples; the distal aspect of the incision was notable for dehiscence and friable edges with underlying purulence, wound was fully opened, and all suture materials were removed.After 258 months of follow - up there was healing noted.No known post-operative complications reported.Patient outcome is unknown.No further information is available.This report is for an unknown elite bone staple.This is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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