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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date the patient underwent an unknown procedure for a fixation of bilateral sacral fracture, utilizing a dps sacral bar implant 260 mm with nuts and washers (stainless steel).Healing was assumed because of some bridging callus visible on last x-ray.Postoperatively, there was hematoma and bleeding anemia.Reoperation was due to bleeding and hematoma.Patient outcome is unknown.No further information is available.This report is for one (1) 6.0mm threaded sacral bar 260mm.This is report 1 of 1 for complaint (b)(4).
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