{"id":"2ab3fa67-bb0e-4c53-9036-0ec5c647033c","slug":"rex-bionics-femur-fracture-2016","kind":"injury","headline":"REX exoskeleton session resulted in bilateral femur fractures in a spinal cord injury patient with osteoporosis","summary":"A 50-year-old female spinal cord injury patient sustained bilateral symmetrical bone fractures during a REX rehabilitation session. The FDA MAUDE report (MDR 3010365481-2016-00001) found no device defect — the fractures were caused by a combination of patient osteoporosis, improperly secured heel stops during a spasm, and ankle-foot orthoses restricting range of motion below REX requirements. The manufacturer issued a field safety notification to reinforce heel stop and AFO usage instructions. 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Founded in Auckland in 2003, the company pioneered Robot-Assisted Physiotherapy (RAP) and ran the RAPPER II clinical trial across leading neuro-rehabilitation clinics in the UK and Australia. 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The FDA MAUDE report (MDR 3010365481-2016-00001) found no device defect — the fractures were caused by a combination of patient osteoporosis, improperly secured heel stops during a spasm, and ankle-foot orthoses restricting range of motion below REX requirements. The manufacturer issued a field safety notification to reinforce heel stop and AFO usage instructions. 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