It was reported that during an indirect decompression spacer implant procedure, the physician was unable to successfully implant the spacer between the fourth and fifth lumbar vertebral level.The company representative was present for the procedure and had expressed multiple times to the physician that the implant appeared to be deeper than the targeted position in the patients anatomy via x-ray imaging.Despite this, the physician assessed that the patients anatomy was not conducive to a successful implant of the spacer and therefore decided to remove the spacer.Removal was difficult because the spacer had already been deployed ventral to the lamina and the physician had to remove tissue and ligament to reach the device.Additionally, the spindle cap had broken during the procedure.After the implant was removed, it was accidentally dropped on the operating room floor.The device will not be returned as it was disposed by the medical facility.A new implant was opened and used to continue the procedure.Postoperatively, the patient experienced neurological deficits wherein the patient was unable to move her legs.Magnetic resonance imaging (mri) confirmed an epidural hematoma around the fourth and fifth lumbar vertebral level.The physician assessed that the cause of the neurological deficits was due to the hematoma and the hematoma was likely due to the traumatic removal of the implant that was placed too ventrally.The patient was hospitalized and underwent an emergency surgery to make repairs to the affected area.The patient was then placed in spinal cord rehabilitation.
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