EXOGEN ULTRASOUND BONE HEALING SYSTEM

Description of Event or Problem

INCLUDING TOTAL ANKLE; REPLACE AFTER USING THE EXOGEN BIOVENTUS BONE GROWTH STIMULATOR PRESCRIBED BY MY PODIATRIST AND SUPPLIED BY A REPRESENTATIVE OF EXOGEN. I WAS INSTRUCTED TO USE THIS BONE GROWTH STIMULATOR ON MY ANKLE FOR AN APPARENT OSTEOPHYTE AT THE LOCATION OF MY INNER TIBIA BONE. THE OUTWARD RESULT BACKED UP BY CAT SCAN AND REMARKS FROM SURGEON INDICATED THIS DEVICE CAUSED MY ANKLE TO COLLAPSE AND BEGIN TO FUSE AFTER ONLY FOUR APPLICATIONS OF 20 MINUTES PER APPLICATION I WAS UNABLE TO WALK AFTER THE 4TH. I BELIEVE THIS DEVICE WAS TOTALLY PRESCRIBED FOR USE IN THE WRONG AREA AS I HAD SEVERE ARTHRITIS IN AND AROUND ALL THE BONES IN MY RIGHT ANKLE. THIS BONE GROWTH STIMULATOR CAUSED THIS ARTHRITIS TO FUSE ALL OF THESE BONES TOGETHER. FURTHER COMMENTS FROM THE SURGEON, DR. (B)(6) IN (B)(6). INDICATED THERE WERE SOME ABNORMAL GROWTHS ON THE TIBIAL BONE OF SHELF TYPE GROWTHS. THIS COMMENT AMONG OTHERS WERE RATHER MUTED DUE TO THE FACT I BELIEVE DOCTORS DO NOT LIKE TO BAD MOUTH OTHER DOCTORS. FDA SAFETY REPORT ID # (B)(4).