Visual, dimensional, functional and material analyses could not be performed because the device was disposed of by the hospital.Manufacturing records and device history records were reviewed for the corresponding lot and no relevant issues were identified.No complication was noted during the initial surgery, the patient had good bone quality, and excessive force was not applied by surgeon.The patient's post-operative activity is unknown.The patient did not fuse.During revision surgery the distal half of screw could not be explanted and remains implanted in the patient with no reported adverse consequence.From the es2 surgical technique, "internal fixation appliances are load sharing devices which are used to obtain alignment until normal healing occurs.In the event that healing is delayed, does not occur, or failure to immobilize the delayed/nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture." the patient was not fused fifteen months after the initial surgery.The root cause of reported es2 screw fracture is likely delayed union or non-union which lead to excessive and repeated stresses on the device.
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