REX exoskeleton session resulted in bilateral femur fractures in a spinal cord injury patient with osteoporosis
[INJURY]May 2, 2016 · Rex Bionics · Rex Bionics REX · New Zealand, Oceania
Failure Mode
INJURY
Event Date
May 2, 2016
Primary Entity
Rex Bionics
Robotic Platform
Rex Bionics REX
Jurisdiction / Location
New Zealand, Oceania
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5793129
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5793129
- Inspect Filing
https://pmc.ncbi.nlm.nih.gov/articles/PMC5562031/
https://pmc.ncbi.nlm.nih.gov/articles/PMC5562031/
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Details
Incident Context & FAQ
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 at New Zealand, Oceania.
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.