_Incident · Injury_

# REX exoskeleton session resulted in bilateral femur fractures in a spinal cord injury patient with osteoporosis

Canonical ID: `2ab3fa67-bb0e-4c53-9036-0ec5c647033c`

- **Occurred:** 2016-05-02
- **Kind:** `injury`
- **Status (derived):** active
- **Model:** [Rex Bionics REX](/models/rex-bionics-rex.md) (id: `903ee67a-dfdf-40d8-9ae1-7684202783a2`)
- **Company:** [Rex Bionics](/companies/rex-bionics.md) (id: `a20476b2-994c-4fba-a189-382fce9c9c3c`)
- **Category:** [Exoskeletons](/exoskeletons)

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. The event was classified as a Serious Injury by the FDA.

## Sources (2)

1. **MAUDE Adverse Event Report: REX BIONICS LTD REX REHAB** · https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5793129
2. https://pmc.ncbi.nlm.nih.gov/articles/PMC5562031/

## Common questions

### What happened in REX exoskeleton session resulted in bilateral femur fractures in a spinal cord injury patient with osteoporosis?

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. The event was classified as a Serious Injury by the FDA.

### When did this incident occur?

The incident is recorded as occurring on May 2, 2016 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.

### What robot was involved in REX exoskeleton session resulted in bilateral femur fractures in a spinal cord injury patient with osteoporosis?

Rex Bionics REX by Rex Bionics is the recorded robot involved in this incident.

### Has anyone responded to REX exoskeleton session resulted in bilateral femur fractures in a spinal cord injury patient with osteoporosis?

No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.

### What is the current status of REX exoskeleton session resulted in bilateral femur fractures in a spinal cord injury patient with osteoporosis?

This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.


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