Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.From the xia ifu: 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.Early mechanical loosening may result from inadequate initial fixation, latent infection, premature loading of the prosthesis, or trauma.Late loosening may result from trauma, infection, biological complications or mechanical problems, with the subsequent possibility of bone erosion, migration and/or pain.Loss of screw purchase post operatively can be caused by improper screw hole prep, and/or improper screw insertion according to the risk file.Additionally, according to the ifu, early mechanical loosening may result from inadequate initial fixation, latent infection, premature loading of the prosthesis, or trauma.However, the root cause could not be determined conclusively.
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