The implant did not return for evaluation.The original surgery date is unknown.Radiograph images were not provided.The report could not be confirmed.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.The root cause could not be determined.Labeling review: "postoperative management: postoperative management by the surgeon, including instruction and warning and compliance by the patient, of the following is essential: patient should be informed and compliant with the purpose and limitations of the implant devices.The surgeon should instruct the patient regarding amount and time frame after surgery of any weight bearing activity.The increased risk of bending, dislocation, and/or breakage of the implant devices, as well as an undesired surgical result are possible consequences of any type of early or excessive weight bearing, vibratory motion, fall, jolts or other movements preventing proper healing and/or fusion development.".
|