RIALTO SI FUSION SYSTEM

Additional Manufacturer Narrative

MEHUL SARKAR, JOSEPH MAALOULY, SAMEER RUPAREL, JOHN CHOI SACROILIAC JOINT FUSION: FUSION RATES AND CLINICAL IMPROVEMENT USING MINIMALLY INVASIVE APPROACH AND INTRAOPERATIVE NAVIGATION AND ROBOTIC GUIDANCE HTTPS://DOI.ORG/10.31616/ASJ.2021.0058. 3005739886-2022-00007 MEAN AGE OF 67 YEARS (RANGE 33 TO 88 YEARS). THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 27 FEMALES AND 16 MALE PATIENTS. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PATIENT HAD FRACTURE AT THE MID POINT OF S2 SCREW. DATE THAT THE ARTICLE WAS ACCEPTED FOR AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. PRODUCT CODE IS UNKNOWN. PRODUCT IDENTIFIERS ARE UNKNOWN. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. 510(K)# IS UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

MEHUL SARKAR, JOSEPH MAALOULY, SAMEER RUPAREL, JOHN CHOI: SACROILIAC JOINT FUSION: FUSION RATES AND CLINICAL IMPROVEMENT USING MINIMALLY INVASIVE APPROACH AND INTRAOPERATIVE NAVIGATION AND ROBOTIC GUIDANCE: HTTPS://DOI.ORG/10.31616/ASJ.2021.0058 SUMMARY: A TOTAL OF 43 PATIENTS UNDERWENT 60 SI JOINT FUSIONS. THE COHORT COMPRISED 27 FEMALES AND 15 MALES WITH A MEAN AGE OF 66±14 YEARS (RANGE, 33¿88 YEARS). . AMONG THE 43 PATIENTS, 26 UNDERWENT UNILATERAL SI JOINT FUSION AND 17 UNDERWENT PRIMARY BILATERAL JOINT FUSION. THE PATIENTS WERE PLACED UNDER GENERAL ANESTHESIA AND POSITIONED PRONE ON A WILSON FRAME. STERILE DRAPING WAS PERFORMED TO EXPOSE BOTH THE BUTTOCKS AND LOWER BACK. A 5-MM LONGITUDINAL STAB INCISION WAS MADE OVER THE POSTERIOR SUPERIOR ILIAC SPINE FOR PLACING THE NAVIGATION REFERENCE FRAME TO PROVIDE AN IMAGING REFERENCE FOR THE STEALTH NAVIGATION SYSTEM (MEDTRONIC) OR EXCELSIUS GPS ROBOTIC NAVIGATION PLATFORM. AN INTRAOPERATIVE CT SCAN WAS OBTAINED USING THE O-ARM 2 SYSTEM. THE CT SCAN WAS INTEGRATED TO THE STEALTH NAVIGATION SYSTEM (MEDTRONIC) AND THE EXCELSIUS GPS ROBOTIC NAVIGATION PLATFORM. USING THE NAVIGATION INSTRUMENT, THE ENTRY POINTS TO ACCOMMODATE TWO OR THREE SCREWS IN DIFFERENT PLANES WERE MARKED ON THE SKIN AFTER CONFIRMING TRAJECTORY ON AXIAL, SAGITTAL, AND CORONAL IMAGES AT THOSE LEVELS. A SMALL 1.5-CM INCISION WAS MADE OVER EACH MARKED SKIN, WHICH WAS CARRIED DEEP TO THE BONE LEVEL. USING A NAVIGATED CANNULA, A GUIDE PIN WAS PLACED AS PERPENDICULAR TO THE SYNOVIAL SI JOINT AS POSSIBLE. THEN, A NAVIGATED HIGH-SPEED DRILL WAS PASSED WHILE KEEPING THE TRAJECTORY USING THE NAVIGATION INTERFACE. THE MOST COMMON PATTERN USED WAS ONE SCREW WITHIN EACH OF S1 AND S2. THE LENGTH AND DIAMETER OF EACH IMPLANT WERE ESTIMATED BASED ON NAVIGATED PROJECTIONS. IN ROBOTIC-GUIDED CASES, SCREWS WERE PLACED USING PREPLANNED TRAJECTORIES ON THE CT SCAN NAVIGATION INTERFACE OF THE ROBOT. CONVENIENT DIRECT PLACEMENT OF SCREWS WAS POSSIBLE THROUGH THE INCISION AFTER DRILLING AND TAPPING THROUGH THE RIGID ROBOT ARM. FIXATION WAS PROVIDED USING CANNULATED SCREWS (RIALTO SI FUSION SYSTEM) FILLED WITH ALLOGRAFT BONE AND BONE MORPHOGENETIC PROTEIN (BMP) (INFUSE RHBMP2). ALL SCREWS WERE NAVIGATED AND PLACED. ONE-THIRD OF THE 1.8- MG INFUSE WAS USED FOR EACH SCREW. ALL INCISIONS WERE CLOSED IN STANDARD FASHION. IN THE POSTOPERATIVE PERIOD, THE PATIENTS WERE ALLOWED IMMEDIATE WEIGHT BEARING AND MOBILIZATION AS TOLERATED. REPORTED EVENTS: ONE PATIENT HAD EVIDENCE OF FRACTURE AT THE MIDPOINT OF THE S2 SCREW, WHICH WAS MONITORED OVER THE NEXT 3 MONTHS AND HEALED COMPLETELY AT THE 6-MONTH FOLLOW-UP WITH FUSION ACROSS THE SI JOINT. TWO PATIENTS HAD EVIDENCE OF HALO AROUND THE S2 SCREW DETECTED 6 MONTHS AFTER FUSION, WHICH WAS REPLACED WITH A LARGER SCREW IN ONE INSTANCE AND AUGMENTED WITH A THIRD SCREW IN THE OTHER. LOOSENESS WAS OBSERVED IN 2 SCREWS AND WERE REPLACED DURING REVISION SURGERY.