Description of Event or Problem · 1
A (B) (6) MALE WITH PRIOR L3-4 SURGERY IN 2001 WAS ADMITTED TO THE HOSPITAL (B) (6) 2010 WITH DEGENERATIVE SPONDYLOLISTHESIS AT L3-4 FOR A DIRECT LATERAL INTERBODY FUSION WITH AN ANTERO-LATERAL PLATE FIXATION. DURING THE OPERATIVE PROCEDURE AFTER AN ATTEMPT TO REPOSITION THE ANTERIOR L4 VERTEBRAL SCREW, BLEEDING OCCURRED THROUGH THE SCREW HOLE AND WAS ADDRESSED. THE OPERATIVE WOUND WAS CLOSED. THE PT THEN HAD A DROP IN BLOOD PRESSURE WHICH INDICATED A VASCULAR INJURY. MULTIPLE SURGEONS CAME TO THE OPERATING ROOM TO CONTROL THE PT'S RETROPERITONEAL BLEEDING. THE PT RECEIVED MULTIPLE TRANSFUSIONS AND BLOOD SPLIT PRODUCTS. FOLLOWING LIGATION OF THE INFERIOR VENA CAVE AND THE RIGHT AND LEFT COMMON ILIAC VEINS, THE PT WAS MOVED TO ICU. THE PT THEN LOST HIS BLOOD PRESSURE AND DEVELOPED A CARDIAC ARRHYTHMIA. DESPITE CARDIO-PULMONARY RESUSCITATION THE PT EXPIRED. CAUSE OF DEATH WAS ACUTE BLOOD LOSS ANEMIA FROM INITIAL INFERIOR VENA CAVA LACERATION WHICH PROGRESSED TO VENA CAVA TRANSECTION. THE SURGEON STATED THE DESIGN OF THE ANTERO-LATERAL PLATE WAS THE PROBLEM IN THIS SERIOUS ADVERSE EVENT. THE SURGEON STATED THAT HE NOTIFIED SYNTHES SPINE INC OF THE PROBLEM WITH THE FIRST GENERATION ORACLE PLATE UTILIZED IN THIS OPERATION. THIS PT EXPIRED AND WAS AUTOPSIED. THE MEDICAL EXAMINER MAY HAVE THE ORACLE PLATE SAVED.