NUVASIVE X-CORE EXPANDABLE VBR SYSTEM, NUVASIVE X-CORE MINI CERVICAL EXPANDABLE

Description of Event or Problem

ON (B)(6) 2022 A PATIENT UNDERWENT A POSTERIOR VERTEBRAL REPLACEMENT PROCEDURE FROM L3 TO L5. AND THE SURGERY WAS COMPLETED WITHOUT ISSUE. ON (B)(6) 2022 IT WAS DISCOVER DURING A POSTOPERATIVE X-RAY THAT THE IMPLANTED CORE REPLACEMENT HAD MIGRATED AT L4. THE PATIENT WAS NOT REPORTED TO BE EXPERIENCING ANY PAIN OR ADVERSE CONSEQUENCES AS A CONSEQUENCE OF THE DEVICE MIGRATION. ON (B)(6) 2022 A REVISION OCCURRED WHERE THE MIGRATED IMPLANT WAS REPOSITIONED AND THE EXPANSION LEVEL WAS ADJUSTED WITHOUT ISSUE. THE PATIENT IS REPORTED TO BE DOING WELL POST REVISION.

Additional Manufacturer Narrative

NO DEVICE WAS RETURNED AS IT REMAINS IN-SITU AND NO RADIOGRAPHS COULD BE PROVIDED CONFIRMING THE ALLEGED COMPLAINT. THE PATIENTS-OP ACTIVITY LEVELS ARE UNKNOWN. THE ROOT CAUSE OF THE EVENT IS UNKNOWN BUT REVIEW OF THE PROVIDED INFORMATION SUGGESTS INSUFFICIENT IMPLANT EXPANSION THAT WAS CORRECTED DURING THE REPORTED REVISION. NO PRODUCT FAILURE REPORTED AND NO ADDITIONAL INVESTIGATION IS REQUIRED. LABEL 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." POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S)." 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. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. THE POTENTIAL FOR SUCCESS IS INCREASED BY THE SELECTION OF THE PROPER SIZE OF THE IMPLANT." PATIENT EDUCATION: PREOPERATIVE INSTRUCTIONS TO THE PATIENT ARE ESSENTIAL. THE PATIENT SHOULD BE MADE AWARE OF THE LIMITATIONS OF THE IMPLANT AND POTENTIAL RISKS OF THE SURGERY. THE PATIENT SHOULD BE INSTRUCTED TO LIMIT POSTOPERATIVE ACTIVITY, AS THIS WILL REDUCE THE RISK OF BENT, BROKEN OR LOOSE IMPLANT COMPONENTS. THE PATIENT MUST BE MADE AWARE THAT IMPLANT COMPONENTS MAY BEND, BREAK OR LOOSEN EVEN THOUGH RESTRICTIONS IN ACTIVITY ARE FOLLOWED." TO OBTAIN A SURGICAL TECHNIQUE MANUAL OR SHOULD ANY INFORMATION REGARDING THE PRODUCTS OR THEIR USES BE REQUIRED, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR NUVASIVE DIRECTLY AT +1-800-475-9131. YOU MAY ALSO EMAIL: INFO@NUVASIVE.COMDEVICE REMAINS IN-SITU.