NUVASIVE COROENT THORACOLUMBAR INTERBODY

Additional Manufacturer Narrative

THE DEVICE WAS RECEIVED BY NUVASIVE AND THE COMPLAINT WAS NOT CONFIRMED AS FRACTURED BUT RATHER A STRIPPED ATTACHMENT FEATURE. EXAMINATION REVEALED THE PROXIMAL ATTACHMENT FEATURES INTERNAL THREADS ARE COMPLETELY STRIPPED OUT WITH A PIECE OF THREAD SEPARATED FROM THE BODY, ADDITIONALLY THERE TWO GOUGES ON THE SUPERIOR SURFACE OF THE PROXIMAL END AS WELL AS ONE ON THE TOP SURFACE CONSISTENT WITH INSTRUMENT CONTACT POSSIBLY DURING REMOVAL. REVIEW OF THE DAMAGE OBSERVED IS CONSISTENT WITH EXCESSIVE FORCE DURING INSERTER ATTACHMENT (OVERTIGHTENING) DAMAGING THE THREADS OR INSUFFICIENT ENGAGEMENT OF THE INSERTER ALLOWING MICROMOTION AND PISTONING DURING IMPACTION RESULTING IN THREAD DAMAGE, INDICATING A PROCEDURAL ERROR AS THE ROOT CAUSE OF THE REPORTED EVENT. NO ADDITIONAL INVESTIGATION REQUIRED. MANUFACTURING REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS OF ALL DEVICES NOTES NO MATERIAL NON-CONFORMANCES, NO MANUFACTURING ERRORS, NOR DISCREPANCIES WITH RESPECT TO MATERIAL TYPE, TREATMENTS, DIMENSIONS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS MODE OF FAILURE. 25 DEVICES MET ACCEPTANCE CRITERIA UPON RELEASE ON JUNE 02, 2021 WITH NO OTHER COMPLAINTS IDENTIFIED FOR LOT N296333 AT THIS TIME. LABELING REVIEW: "...WARNINGS, CAUTIONS AND PRECAUTIONS: 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..." "...ALL COMPONENTS SHOULD BE FINAL TIGHTENED PER THE SPECIFICATIONS IN THE SURGICAL TECHNIQUE. IMPLANTS SHOULD NOT BE TIGHTENED PAST THE LOCKING POINT, AS DAMAGE TO THE IMPLANT MAY OCCUR. NOTCHING, STRIKING, AND/OR SCRATCHING OF IMPLANTS WITH ANY INSTRUMENT SHOULD BE AVOIDED TO REDUCE THE RISK OF BREAKAGE..." "...COMPATIBILITY: ALL IMPLANTS SHOULD BE USED ONLY WITH THE APPROPRIATELY DESIGNATED INSTRUMENT (REFERENCE SURGICAL TECHNIQUE)..." "...PRE-OPERATIVE WARNINGS: CARE SHOULD BE USED IN THE HANDLING AND STORAGE OF THE COROENT IMPLANTS. THE IMPLANTS SHOULD NOT BE SCRATCHED OR DAMAGED. IMPLANTS AND INSTRUMENTS SHOULD BE PROTECTED DURING STORAGE AND FROM CORROSIVE ENVIRONMENTS. 5. CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT..." "...METHOD OF USE: PLEASE REFER TO THE SURGICAL TECHNIQUE FOR THIS DEVICE..." "...INFORMATION: 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 (B)(6). YOU MAY ALSO EMAIL: INFO@NUVASIVE.COM. THIS INSTRUCTIONS FOR USE DOCUMENT IS INTENDED FOR THE US MARKET ONLY. FOR OUS INSTRUCTIONS FOR USE, PLEASE REFER TO DOCUMENT #9402700 FOR NON-STERILE IMPLANTS AND #9401726 FOR STERILE IMPLANTS. 9402012-EN..."

Description of Event or Problem

NEW INFORMATION LISTED IN SECTION H10.

Additional Manufacturer Narrative

THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED TO NUVASIVE FOR EVALUATION; FURTHER, NO OPERATIVE NOTES AND/OR RADIOGRAPH IMAGES WERE PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A REVIEW OF DEVICE MANUFACTURING RECORDS WAS PERFORMED AND NO DISCREPANCIES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION PROVIDED. LABELING REVIEW: "POTENTIAL ADVERSE EVENTS AND COMPLICATIONS: 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 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. WHILE PROPER SELECTION CAN MINIMIZE RISKS, THE SIZE AND SHAPE OF HUMAN BONES PRESENT LIMITATIONS ON THE SIZE AND STRENGTH OF IMPLANTS." "PRE-OPERATIVE WARNINGS: CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT." IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL EXTREME LATERAL INTERBODY FUSION PROCEDURE. DURING THE PROCEDURE, AS THE SURGEON INSERTED THE INTERBODY CAGE INTO THE DISC SPACE USING THE SLIDE INSTRUMENTATION, THE CAGE FRACTURED AT THE PROXIMAL EDGE WHERE IT MATES WITH THE INSERTER. NO INFORMATION WAS PROVIDED REGARDING HOW THE PROCEDURE WAS COMPLETED. NO PATIENT CONSEQUENCES HAVE BEEN REPORTED AS A RESULT OF THE REPORTED ISSUE. NO ADDITIONAL INFORMATION IS AVAILABLE.