NUVASIVE GENERAL INSTRUMENTS

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED AND THE COMPLAINT WAS CONFIRMED. A REVIEW OF THE MANUFACTURING HISTORY FOUND NO MATERIAL NONCONFORMANCE, NO MANUFACTURING ERROR, NOR DISCREPANCIES WITH RESPECT TO MATERIAL TYPE, TREATMENTS OR DIMENSION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. PARTS MET ACCEPTANCE CRITERIA UPON RELEASE. LOT #FD9127220 WAS MANUFACTURED IN OCTOBER OF 2019. EXAMINATION OF THE RETURNED DEVICE WAS COMPLETED BY NUVASIVE AND THE FRACTURE PATTERN IDENTIFIED IS CONSISTENT WITH EXCESSIVE FORCE. REVIEW OF THE RETURNED DEVICE AND REPORTED EVENT SUGGESTS THE FRACTURE WAS THE RESULT OF OFF-ANGLED EXCESSIVE FORCE DURING USE AND CONSIDERED PHYSICAL FIELD DAMAGE. NO ADDITIONAL INVESTIGATION NECESSARY. 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." "DO NOT IMPLANT THE INSTRUMENTS: COMPLICATIONS TO THE PATIENT MAY INCLUDE, BUT ARE NOT LIMITED TO: BREAKAGE OF THE DEVICE, WHICH COULD MAKE NECESSARY REMOVAL DIFFICULT OR SOMETIMES IMPOSSIBLE, WITH POSSIBLE CONSEQUENCES OF LATE INFECTION AND MIGRATION. BREAKAGE COULD CAUSE INJURY TO THE PATIENT." "PRE-OPERATIVE WARNINGS: THE METHOD OF USE FOR THE INSTRUMENTS ARE TO BE DETERMINED BY THE USER¿S EXPERIENCE AND TRAINING IN SURGICAL PROCEDURES. THE INSTRUMENTS SHOULD BE TREATED AS ANY PRECISION INSTRUMENT AND SHOULD BE CAREFULLY PLACED ON TRAYS, CLEANED AFTER EACH USE, AND STORED, ACCORDING TO GENERALLY ACCEPTED HOSPITAL METHODS AND PRACTICES. THE INSTRUMENTS SHOULD BE CAREFULLY EXAMINED PRIOR TO USE FOR FUNCTIONALITY, EXCESSIVE WEAR, OR DAMAGE. A DAMAGED INSTRUMENT SHOULD NOT BE USED AS THIS MAY INCREASE THE RISK OF MALFUNCTION AND POTENTIAL PATIENT INJURY. CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICES AND INJURY TO THE PATIENT." "INTRA-OPERATIVE WARNINGS: THE PHYSICIAN SHOULD TAKE PRECAUTIONS AGAINST PUTTING UNDUE STRESS ON THE SPINAL AREA WITH INSTRUMENTS. ANY SURGICAL TECHNIQUE SHOULD BE CAREFULLY FOLLOWED. IT IS IMPORTANT THAT THE SURGEON EXERCISE EXTREME CAUTION WHEN WORKING IN CLOSE PROXIMITY TO VITAL ORGANS, NERVES, OR VESSELS, AND THAT THE FORCE APPLIED TO THE INSTRUMENTATION IS NOT EXCESSIVE, TO PREVENT POTENTIAL INJURY TO THE PATIENT. OVER-BENDING, NOTCHING, STRIKING, AND/OR SCRATCHING OF IMPLANTS WITH ANY INSTRUMENT SHOULD BE AVOIDED TO REDUCE THE RISK OF BREAKAGE. THE PHYSICAL CHARACTERISTICS REQUIRED FOR MANY INSTRUMENTS DO NOT PERMIT THEM TO BE MANUFACTURED FROM IMPLANTABLE MATERIALS. IF ANY BROKEN FRAGMENTS OF INSTRUMENTS REMAIN IN THE BODY OF A PATIENT, THEY COULD CAUSE ALLERGIC REACTIONS OR INFECTIONS. IF AN INSTRUMENT BREAKS IN SURGERY AND FRAGMENTS GO INTO THE PATIENT, THESE PIECES SHOULD BE REMOVED PRIOR TO CLOSURE AND SHOULD NOT BE IMPLANTED."

Description of Event or Problem

ON (B)(6) 2023 A PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE USING A LATERAL APPROACH ON UNKNOWN LEVELS OF THE SPINE. DURING THE PROCEDURE WHILE REMOVING DISC TISSUE THE DISTAL BITING JAW FRACTURED OFF IN THE PATIENT AND WAS RETRIEVED FROM THE DISC SPACE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THE FAILURE.