Corrected data: d.6.Date of implant updated from blank to ' on (b)(6) 2017'.D.6.Date of explant updated from blank to ' on (b)(6) 2019'.Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Per instructions for use: 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.These implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.After healing occurs, these devices serve no functional purpose and can be removed.Removal may also be recommended in other cases, such as: corrosion with a painful reaction.Migration of the implant, with subsequent pain and/or neurological, articular or soft tissue lesions.Pain or abnormal sensations due to the presence of the implants.Infection or inflammatory reactions.Reduction in bone density due to the different distribution of mechanical and physiological stresses and strains.Failure or mobilization of the implant.Based on the available information, the most likely cause of reported event is normal wear over the time.
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