No device was returned as no product malfunction was suggested.No images were provided to confirm the complaint.Due to the lack of information the root cause cannot be determined however review of the provided information suggests the patient's lack of mobility and anatomical condition may be the cause or contributor.No additional investigation can be completed at this time.Labeling review: "potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection.Potential risks identified with the use of this system, which may require additional surgery, include: infection." "warnings, cautions and precautions: care should be taken to insure that all components are ideally fixated prior to closure." "pre-operative warnings: care should be used during surgical procedures to prevent damage to the devices and injury to the patient.".
|