Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history and complaint history records were reviewed for the provided lot number and no relevant manufacturing issues or similar complaints were identified.From es2 surgical technique: while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.No complication during initial surgery was reported, patient did not experience a fall and performed normal activity level.Patient's bone quality is unknown.Based on available information, an exact root cause could not be determined but may have occurred due to following: instable construct; overtightened blocker; incorrect screw trajectory; poor bone quality/patient pathology.
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