510k: this report is for an unknown rafn end cap/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 the patient underwent a procedure on an unknown date, with retrograde approach for a mal-union of miserable malalignment syndrome.Intra operation bleeding from osteotomy site was noted.Postoperatively, there was no union of fracture noted.Patient had a femoral anteversion deformity with excessive external rotation of tibia.Left sided osteotomies with nail fixation to aid patellar tracking.There was an evidence of healing reported.No further information is available.This report is for an unknown rafn end cap.This is report 3 of 4 for (b)(4).
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