This report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3006630150-2021-07548 for the first superion indirect decompression system.It was reported that the patient was hospitalized with a low grade fever, disorientation, and struggling to control his blood sugar.When the patient was admitted to the hospital, it was found that the patient had elevated white blood cells.A mri was performed and an epidural hematoma or localized infection were ruled out.It was also noted that the patient did not respond well to the anesthesia or the recovery process following the initial implant procedure.The patient had disorientation and the physician decided to explant the two spacers.
|