MARVEL

Additional Manufacturer Narrative

THE MARVEL ROD FRACTURE WAS DISCOVERED VIA X-RAY IMAGING ON (B)(6) 2025, FOURTEEN MONTHS AFTER THE ROD WAS INSERTED. THE FRACTURED ROD WAS REMOVED IN A REVISION PROCEDURE PERFORMED ON (B)(6) 2025. THE EXPLANTED MARVEL ROD WAS SAID TO HAVE SHIPPED BACK TO GLOBUS ON (B)(6) 2025. NO PART WAS RECEIVED, BUT SEVERAL IMAGES OF THE FRACTURED IMPLANT WERE PROVIDED. IT WAS DETERMINED THAT THE PATIENT WAS 13 YEARS OLD AT THE TIME OF THE REVISION PROCEDURE AND WAS 11.5-12 YEARS OLD DURING INITIAL IMPLANTATION. MARVEL GROWING RODS ARE INDICATED FOR PATIENTS UNDER 10 YEARS OF AGE. THE INCREASED STRESS THESE RODS MAY BE SUBJECTED TO FROM OLDER, LARGER PATIENTS CAN POSSIBLY CONTRIBUTE TO EARLY ROD FRACTURES (PRIOR TO 2 YEARS POST-OP) IN THESE DYNAMIC, NON-FUSION CONSTRUCTS. THE PROVIDED X-RAY IMAGES CONFIRM THAT THE LEFT MARVEL GROWING ROD'S FIXED ROD EXPERIENCED A FATIGUE FRACTURE BETWEEN THE HOUSING AND THE UPPERMOST LUMBAR FIXATION POINT. THE CONSTRUCT X-RAY IMAGES SHOW THE FRACTURED ROD'S HOUSING WAS POSITIONED IN THE MID-THORACIC REGION (T8-T11), WITH SCREWS PLACED AT L2 AND L3. THE PROVIDED VIDEOS ALSO SHOWED THE EXPANSION ROD FREELY ROTATING WITHIN THE IMPLANT HOUSING. WITH NO PART RETURNED, THE EXACT CAUSE OF FAILURE COULD NOT BE ESTABLISHED AS FURTHER INVESTIGATION WAS NOT POSSIBLE. MANUFACTURING DOCUMENTATION WAS REVIEWED FOR THIS PART AND NO NON-CONFORMANCES WERE IDENTIFIED. A PROTOCOL DEVIATION IS NOTED, BUT THIS CHANGE WAS INCORPORATED INTO THE VALIDATION AND APPROVED REVISION D PRINTS. THE PRODUCT IS WITHIN THE ANTICIPATED RISK; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED AND WILL CONTINUE TO BE MONITORED. CLARIFICATION FROM THE SALES REP RECEIVED ON 23 MAR 2026 PROVIDED ADDITIONAL INFORMATION THAT CHANGED GLOBUS' UNDERSTANDING OF THE EVENT, MAKING THIS EVENT REPORTABLE. ORIGINALLY, GLOBUS INTERPRETED THE REP'S EMAIL RESPONSES THAT A REVISION PROCEDURE WAS ALREADY PLANNED FOR THIS PATIENT, AND THE ROD WAS SUBSEQUENTLY FOUND TO BE FRACTURED AND WAS THEN REMOVED. IN THE DISCUSSION HELD ON (B)(6) 2026, IT WAS DETERMINED THE REVISION PROCEDURE WAS PLANNED IN DIRECT RESPONSE TO DISCOVERING THE ROD FRACTURE, MAKING THIS AN UNPLANNED RETURN TO THE OPERATING ROOM AND THEREFORE A REPORTABLE EVENT.

Description of Event or Problem

IT WAS REPORTED THAT AFTER FOURTEEN MONTHS AFTER THE ROD WAS INSERTED IN AN XRAY REVEALED A ROD FRACTURE CLOSE TO LUMBAR SCREWS. THE ROD WAS REMOVED DURING SURGERY, DISINFECTED, PACKED AND PREPARED FOR SHIPMENT.