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It was reported that a (b)(6) male patient with osteogenesis imperfecta and multiple sclerosis was scheduled for outpatient surgery on (b)(6) 2012 for a comminuted right patella fracture sustained after a fall.A magnetic resonance imaging (mri) scan performed that same day due to patient complaints of left groin pain for several months showed an occult intertrochanteric left hip fracture.On (b)(6) 2012, the patient underwent intramedullary nailing of his left hip and open reduction internal fixation (orif) of the right patella.The orif to the right patella placed without incident.During procedure to the left hip, the patient sustained a minimally displaced supracondylar femur fracture when the surgeon attempted to insert the 11 x 360 synthes nail.The surgeon noted in the operative report that the fracture was due to the osteogenesis imperfecta.During subsequent placement of the helical blade, it did bind up in the nail.It could not be removed.During the attempted removal of the nail and bound blade, the lateral cortex for approximately half the length of the femur split.Once the nail was removed, inspection on the back table showed metal shavings.The blade bound up in the nail.When the nail was placed, the set screw was fully deployed or rather distally deployed which caused binding of the blade through the nail.Subsequently, cortical femoral struts, multiple synthes wires and those of competitor were placed to reduce the multiple fractures.The new nail was then locked in place.The surgeon placed a single cerclage wire to reduce the not comminuted, full-length femur fracture.The patient was then transferred from the hip fracture table onto a (b)(4) table to prep the left lower extremity.Using a lateral approach to the distal femur at the left knee, the surgeon slid up from distal to proximal a synthes pre-contoured distal femur plate.The surgeon placed three unicortical locking screws proximally, completed the box distally with a 6.5 screw and multiple cannulated 50 and 55 synthes screws.Percutaneous locking screw placement was reported.The skin was closed.In the act of straightening the left leg, a knee immobilizer was placed.The proximal aspect of the plate pulled off the bone due to the osteogenesis imperfecta per surgeon, causing the fracture.The c-arm documented this new fracture.There was no more clean equipment.The patient was transferred to the post anesthesia care unit (pacu) in good condition with the left lower extremity placed in a knee immobilizer.He was advised the following day, (b)(6) 2012, that another fracture developed and that he would need further surgery.On (b)(6) 2012 the patient underwent orif of the left junction of middle third and distal third femur fracture.The surgeon placed three synthes cerclage wires around the proximal aspect of the plate, removed prior locking screws from the plate.The surgeon made sure the fracture was well reduced and placed three synthes cables, which were appropriately tensioned and crimped.Medical records indicated bone graft to femur.Final fluoroscopy demonstrated adequate reduction.The patient was closed and brought to the pacu in good condition.He was subsequently discharged in good condition on (b)(6) 2012 to rehabilitation.Patient status for post-operative rehabilitation included right knee immobilizer and left lower extremity (lle) nonweight bearing with maximum assistance required for transfers and lower extremity activities of daily living (adls).Multidisciplinary therapies were planned for at least three hours a day, five to seven days a week, in order for the patient to be modified independent with transfers and adls.At time of discharge on (b)(6) 2012 to a long term care facility, the patient was unable to get to modified independence due to his non weight bearing lle.In (b)(6) 2012, the patient progressed in physical therapy from lle non weight bearing to left hinged knee brace, flexion to 70 degrees.In (b)(6) 2012, the patient was using a rolling walker.A leg length shortening of several centimeters was noted on (b)(6) 2012 x-ray records.Medical records indicated the patient was to have a custom three quarter inch heel lift for his left heel.Patient was subsequently discharged from therapy.Medical records indicate numerous office visits and radiographs taken throughout the summer of 2012 with reports of pain ranging from moderate to none, and healing distal femur and hip fracture.Subsequent radiographs taken (b)(6) 2012 and (b)(6) 2013 relate left femoral head necrosis and progressive osteonecrosis.Medical notes dated (b)(6) 2013 indicate patient had one inch lift in his shoe; five/five hip flexion right versus left five/five knee flexion versus left.Impression: status post intertrochanteric hip fracture doing fine; plan for weight bearing as tolerated and light exercise.This is report 15 of 16 for complaint (b)(4).
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This device was used for treatment, not diagnosis.This report is for unknown 18 guide wire.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Placeholder.
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