510k: this report is for an unknown rafn spiral blade/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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It was reported that patient underwent a procedure on an unknown date, using retrograde approach for a supracondylar fracture including those with intraarticular ext.And ballistic at supracondylar femur.Postoperatively, there was no known fracture noted.Patient experienced recalcitrant nonunion.Patient was shot with an ak-47.5in bone defect.Treated with retrograde rafn and cement spacer.Masquelet technique at 3 months.Didn't fully heal and implant was removed without failure and replaced with non-synthes retrograde nail and repeat grafting.There was an evidence of healing reported.No further information is available.This report is for an unknown rafn spiral blade.This is report 1 of 5 for (b)(4).
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