510k: this report is for an unknown cement/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 on an unknown date the patient underwent a hardware removal from the left hip.The trochanteric femoral nail advanced (tfna) nail, unknown 85mm helical blade, unknown distal locking screw were removed due to an unknown reason.The reporter commented that the x-ray revealed an augment of cement present.The patient outcome was unknown.This report is for one (1) unknown cement.This is report 4 of 4 for (b)(4).
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