510k: this report is for an unknown 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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It was reported that the patient underwent a foot osteotomy on an unknown date.Postoperatively, patient had a reoperation due to loss of fixation due to poor bone quality and poor compliance, revision from staple to screw.After 112 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 bone staple.This is report 1 of 1 for (b)(4).
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