Visual, dimensional, functional inspection, and material analysis could not be performed as the device was not returned.Complaint history records were not reviewed as a valid lot number was not provided and could not be obtained.Manufacturing history records were not reviewed as a valid lot number was not provided and could not be obtained.There were no complications during the initial surgery.It was confirmed that the screw holes were prepared with a drill bit.No further information was available regarding the patient's health, activity and lifestyle, additionally, the patient did not fuse nor experienced a fall.The root cause of the reported event could not be determined conclusively.Potential root causes: excessive post-op activity by patient (not recommended by surgeon); previous revision surgeries / acdf procedures intraoperative dissections (could have cause a tear from a previous surgery to sensitive anatomy/soft tissue); patient does not follow surgeon instructions; patient over exerts.The surgical technique states: "use of the screw hole preparation instruments including the fixed or variable drill guides, all-in-one drill guides or punch awl with sleeves is required to place screws in the proper trajectory, help prevent damage to implants, difficulty locking the blocker, or locking mechanism malfunction.Patients involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) may be at increased risk for failure of the fusion and/or the device.Surgeons must instruct patients in detail about the limitations of the implants, including, but not limited to, the impact of excessive loading through patient weight or activity, and be taught to govern their activities accordingly.The procedure will not restore function to the level expected with a normal, healthy spine, and surgeons should counsel patient to not have unrealistic functional expectations.Patients who smoke have been shown to have an increased incidence of non- unions.Such patients must be advised of this fact and warned of the potential consequences.".
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