Visual, dimensional, material and functional analysis could not be performed as the device remains implanted in the patient.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed, similar complaints were identified.Follow-up communication was conducted with the sales rep, surgeon, and internal healthcare professional (hcp).The representative reported that there were no adverse events with the patient and no noticeable subsidence of the grafts.The screws appear to be within the angles in the stg.Internal hcp confirms that there is no evidence of cage subsidence.However, it was noted that the cages are not recessed completely into the disc space and that the upper cage appears to be contacting the plate.The plate is not completely approximated to the bone at the upper and lower levels, there is a gap between them.The ozark view and guide surgical technique was reviewed and the following relevant information was identified: internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Loads produced by load bearing and activity levels will impact the longevity of the implant.Implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a bone has healed.If an implant re-mains implanted after complete healing, it can actually increase the risk of refracture in an active individual.The surgeon should weigh the risks versus benefits when deciding whether to remove the implant.Due to the devices remaining implanted and not available for inspection, a definitive root cause could not be determined.Potential causes of fracture include, but are not limited to: patient anatomical factors, patient non-compliance, patient accident/trauma, and/or normal mechanical limitations of the implant(s).The plate potentially resting on the cage may have contributed to the event, but could not be confirmed without devices being returned.
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