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Incident · Injury

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.

Occurred 2016-05-02 · Rex Bionics REX · Rex Bionics · Exoskeletons · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track REX exoskeleton session resulted in bilateral femur fractures in a spinal cord injury patient with osteoporosis

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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.
Methodology: Verified · 2 sources (2 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

1
primary-fda-database
FDA database
1
primary-academic-peer-reviewed
Peer-reviewed clinical / academic

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for REX exoskeleton session resulted in bilateral femur fractures in a spinal cord injury patient with osteoporosis.

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