Description of Event or Problem · 0
THE EVENT HAPPENED IN FRANCE. ON (B)(6) 2024, AT 9:30 AM, THE PATIENT ATTENDED HER FIRST REHABILITATION SESSION WITH THE ATALANTE X EXOSKELETON. THE DONNING PROCESS WAS PERFORMED NORMALLY, AND THE PATIENT DID NOT REPORT ANY DISCOMFORT OR PAIN. THERE WERE NO ISSUES DURING THE SIT-TO-STAND TRANSITION WITH THE DEVICE EITHER. ONCE STANDING, THE PATIENT EXPRESSED DISCOMFORT AT THE LEFT KNEE LEVEL, THOUGH IT WAS NOT PAINFUL. THE SESSION BEGAN WITH WALKING USING SMALL STEPS (EARLYGAIT MODE), WHICH THE PATIENT DID NOT FIND PLEASANT. THE OPERATOR SUGGESTED SWITCHING TO WALKING WITH LARGER STEPS (REALGAIT MODE) TO PROVIDE A MORE "NORMAL" GAIT EXPERIENCE (FOOT ROLLING). HOWEVER, THE PATIENT COMPLAINED THAT THE LEFT TIBIA SUPPORT WAS BOTHERSOME. NOTICING THE DIFFICULTIES THE PATIENT WAS EXPERIENCING, A SECOND OPERATOR INTERVENED TO PERFORM A HALF-TURN WITH THE EXOSKELETON AND BROUGHT IN A BENCH TO CONCLUDE THE SESSION. A TOTAL OF 130 STEPS WERE TAKEN DURING THE SESSION. DURING THE STAND-TO-SIT TRANSITION AT THE END OF THE SESSION, THE PATIENT SUDDENLY SCREAMED IN PAIN AND REPORTED HEARING A CRACK IN HER RIGHT KNEE. THE FOLLOWING DAY, ON (B)(6) , AN X-RAY WAS TAKEN, WHICH WAS INITIALLY INTERPRETED AS NORMAL. HOWEVER, UPON THE PATIENT'S RETURN THE NEXT DAY, THE ORTHOPEDIST SUSPECTED A FRACTURE. A CT SCAN PERFORMED ON (B)(6) CONFIRMED THE PRESENCE OF A FRACTURE. THE PATIENT UNDERWENT SURGERY ON (B)(6) TO INSERT A SINGLE SCREW. FRACTURE DESCRIPTION: ACCORDING TO THE PHYSICIAN IN CHARGE OF THE PATIENT, THE FRACTURE OCCURRED DURING STAND-TO-SIT TRANSITION. IT IS A SPINOTUBEROSITY FRACTURE, WHICH HAS SWEPT BACK THE POSTERIOR SPINE AND PART OF THE TIBIAL PLATEAU. A RECURVATUM (HYPEREXTENSION/BACKWARD BENDING OF THE KNEE) MAY BE INVOLVED. IT IS NOT KNOWN WHETHER THE RECURVATUM WAS STATIC OR DYNAMIC. ADDITIONALLY, THE CT SCAN REVEALED SIGNIFICANTLY THINNED CORTICAL BONE, SUGGESTING PROBABLE OSTEOPENIA. DEVICE INVESTIGATION: THE EXOSKELETON WAS THOROUGHLY INSPECTED FOR ANY POTENTIAL MALFUNCTIONS BY THE WANDERCRAFT TEAM. THE PATIENT INTERFACES (ATTACHMENT SYSTEM WITH STRAPS AND PADDING), OVERALL HARDWARE INTEGRITY, AS WELL AS THE GAIT TRAJECTORY LOGS FROM THE SESSION WERE CAREFULLY ANALYZED. THE RESULTS INDICATE THAT THE DEVICE OPERATED AS EXPECTED, ELIMINATING THE POSSIBILITY OF A TECHNICAL MALFUNCTION. FURTHERMORE, ACCORDING TO THE REPORTS FROM THE THERAPEUTIC TEAM, THE PATIENT'S MEASUREMENTS, THE EXOSKELETON ADJUSTMENT, AND THE SETUP OF THE PATIENT WERE ALL CARRIED OUT CORRECTLY, WHICH SEEM TO EXCLUDE THE POSSIBILITY OF USER ERROR. CONCLUSION: THE INVESTIGATION DEMONSTRATED THAT THE EXOSKELETON FUNCTIONED AS INTENDED. IT DID NOT REVEAL ANY CONTRIBUTING FACTORS FOR THE FRACTURE, WHETHER RELATED TO HARDWARE, SOFTWARE, OR USAGE. MEDICAL OPINIONS CONVERGE IN SUGGESTING THAT THE PATIENT WAS LIKELY OSTEOPOROTIC. A BONE DENSITY TEST HAS BEEN REQUESTED TO FURTHER ASSESS THIS ASPECT. ADDITIONALLY, THE RECURVATUM MAY HAVE BEEN A CONTRIBUTING FACTOR IN THE INCIDENT.