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 procedure on an unknown date, due to arthrodesis foot, deep infection requiring return to or: hardware had to be removed on a second procedure to treat the infection and patient was readmitted at 124 days post-op.After 387 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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