Ekso Bionics EksoGT: lower-back pain on sit-to-stand in a patient with an incompletely healed femur (FDA MAUDE)

[INJURY]

Oct 28, 2020 · Ekso Bionics · EksoNR · United States

Failure Mode

INJURY

Event Date

Oct 28, 2020

Primary Entity

Ekso Bionics

Robotic Platform

EksoNR

Jurisdiction / Location

United States

Audit Standard

Physical State Verified

Incident Abstract & Audit Findings

An FDA MAUDE injury report describes an Ekso Bionics EksoGT user with an incompletely healed femur experiencing lower-back pain during a sit-to-stand transition. Source: FDA MAUDE MDR key 13977353, accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.

System & Fleet Architecture

Operating Manufacturer

Ekso BionicsView Manufacturer

Hardware Platform

EksoNR

Operational Sectors

Primary Sources & Evidentiary Filings

  • https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

  • https://eksobionics.com/

    https://eksobionics.com/

Related Incidents & Failure Precedents

6 records on file

Incident Context & FAQ

What happened in Ekso Bionics EksoGT: lower-back pain on sit-to-stand in a patient with an incompletely healed femur (FDA MAUDE)?

An FDA MAUDE injury report describes an Ekso Bionics EksoGT user with an incompletely healed femur experiencing lower-back pain during a sit-to-stand transition. Source: FDA MAUDE MDR key 13977353, accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.

When did this incident occur?

The incident is recorded as occurring on October 28, 2020 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.

What robot was involved in Ekso Bionics EksoGT: lower-back pain on sit-to-stand in a patient with an incompletely healed femur (FDA MAUDE)?

EksoNR by Ekso Bionics is the recorded robot involved in this incident at United States.

Has anyone responded to Ekso Bionics EksoGT: lower-back pain on sit-to-stand in a patient with an incompletely healed femur (FDA MAUDE)?

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 Ekso Bionics EksoGT: lower-back pain on sit-to-stand in a patient with an incompletely healed femur (FDA MAUDE)?

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