EVANTO

Additional Manufacturer Narrative

THE FOOT HAS BEEN INSPECTED IN DETAIL. THE GENERAL CONDITION IS COMPATIBLE WITH THE SERVICE LIFE OF APPROX. 18.5 MONTHS. THERE ARE SOME SIGNS OF WEAR AND TEAR AND FINE SAND RESIDUE ON THE FOOT AND IN THE FOOTSHELL. THE HEEL STRAP IS TORN LATERALLY OF THE ADAPTER, TOP RIGHT. THE FOOTSHELL IS INTACT. THE STRAP IS WORN, PRESUMABLY BY SAND IN THE ADAPTER/STRAP CONTACT AREA. THE STRAP IS PARTIALLY CRACKED ON THE OPPOSITE SIDE AND WEAR AND TEAR IN OTHER AREAS. THE SUPPORTING SURFACE OF THE STRAP ON THE ADAPTER IS SEVERELY WORN, THE SURFACE IS PARTIALLY SANDED. CONTACT WITH SAND IN THE AREA OF THE SUPPORTING SURFACE OF THE ADAPTER WAS PROBABLY CAUSED BY CONTACT WITH SAND. THE PRODUCT SHOULD BE CLEANED AFTER INTENSIVE CONTACT WITH SAND OR DUST. RELATED INFORMATION IN THE INSTRUCTIONS FOR USE SHOULD BE OBSERVED (SEE CHAPTER 3.3). FAILURE TO FOLLOW THE CLEANING INSTRUCTIONS (SEE IFU CHAPTER 3.3.) SIGNIFICANTLY CONTRIBUTED TO WEAR AND TEAR OF THE BELT. IF THE BELT IS RUPTURED, IT DOES NOT IMMEDIATELY LEAD TO PRODUCT FAILURE, AND THEREFORE DOES NOT ALWAYS LEAD TO A FALL. AT THIS TIME, HOWEVER, WE CANNOT RULE OUT THE POSSIBILITY THAT THE RUPTURE OF THE BELT CONTRIBUTED TO THE FALL. A SERIOUS INJURY OCCURRED AS WELL.

Description of Event or Problem

THE PATIENT REPORTED THAT THE SEQUENCE OF EVENTS IS UNCLEAR. WHILE WALKING FORWARD UNDER NORMAL CONDITIONS, THE PATIENT SUDDENLY EXPERIENCED AN UNDEFINED SENSATION OF THE GAIT BECOMING "SOFT," UNSTABLE, OR GIVING WAY, BEFORE FALLING BACKWARD AND LANDING ON THEIR BACK. THE CPO FOUND, THAT THE HEEL FIXATION STRAP HAD RUPTURED. THE FALL RESULTED IN AN INJURY TO THE L2 VERTEBRA. NO DAMAGE TO THE SPINAL CORD STRUCTURES HAS BEEN IDENTIFIED. THE FALL OCCURED IN NORWAY.