NUVASIVE COROENT THORACOLUMBAR IMPLANTS

Additional Manufacturer Narrative

NO DEVICE WAS RETURNED AS NO DEVICE FAULT WAS ALLEGED. NO IMAGING COULD BE PROVIDED CONFIRMING THE ALLEGED COMPLAINT. REVIEW OF THE REPORTED EVENT IDENTIFIED THE SURGEON MISPLACED THE INTERBODY CAGE AND INADVERTENTLY DAMAGED THE PATIENTS LIGAMENT REQUIRING THE IMPLANT TO BE REMOVED TO BE REPLACED AT A LATER DATE MODIFYING THE PROCEDURE. NO ADDITIONAL INVESTIGATION REQUIRED. LABEL REVIEW: "POTENTIAL ADVERSE EVENTS AND COMPLICATIONS AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN SPINAL/ORTHOPEDIC SURGERY. INFREQUENT OPERATIVE AND POSTOPERATIVE COMPLICATIONS THAT MAY RESULT IN THE NEED FOR ADDITIONAL SURGERIES." "POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: NEUROLOGICAL, VASCULAR OR VISCERAL INJURY." "WARNINGS, CAUTIONS AND PRECAUTIONS THE SUBJECT DEVICE IS INTENDED FOR USE ONLY AS INDICATED. THE IMPLANTATION OF SPINAL SYSTEMS SHOULD BE PERFORMED ONLY BY EXPERIENCED SPINAL SURGEONS WITH SPECIFIC TRAINING IN THE USE OF THIS SPINAL SYSTEM BECAUSE THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF SERIOUS INJURY TO THE PATIENT."

Description of Event or Problem

ON (B)(6) 2024 A LATERAL INTERBODY FUSION PROCEDURE WAS PERFORMED FROM L2 TO L5. WHILE PLACING THE VERTEBRAL SPACER AT THE L4/5 LEVEL IT WAS BELIEVED THAT THE DEVICE WAS POSITIONED TO FAR ANTERIORLY POTENTIALLY INJURING THE ANTERIOR LONGITUDINAL LIGAMENT BUT IT COULD NOT BE CONFIRMED. NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS REPORTED THE CAGE WAS REMOVED WITH PLANS TO IMPLANT A REPLACEMENT AT A LATER DATE.