{"id":"c08f2677-3ea3-4488-b3ab-2b47d449cee0","slug":"ekso-eksogt-lower-back-pain-maude-2020","kind":"injury","headline":"Ekso Bionics EksoGT: lower-back pain on sit-to-stand in a patient with an incompletely healed femur (FDA MAUDE)","summary":"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.","occurredAt":"2020-10-28T00:00:00.000Z","reviewStatus":"reviewed","modelId":"a4a2491a-bfdd-4ba3-b370-771d234bc136","deploymentId":"cbb9eca5-f3b7-4400-a536-a8b6c8b973f6","companyId":"c36c0cb6-a327-458b-94ec-288386588250","dataCenterId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"minor","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":"none","regulatoryBody":"FDA (MAUDE)","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":2,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"formFactor":null,"latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-06-27T10:59:25.935Z","updatedAt":"2026-08-09T05:30:14.099Z","model":{"id":"a4a2491a-bfdd-4ba3-b370-771d234bc136","companyId":"c36c0cb6-a327-458b-94ec-288386588250","modelName":"EksoNR","slug":"ekso-nr","description":"Powered (motor-driven) lower-limb exoskeleton for clinical gait rehabilitation (stroke, spinal-cord injury, acquired brain injury). User intent plus weight-shift triggers powered steps; the device powers the joints, the clinician/patient sets the session. FDA cleared.","formFactor":"exoskeleton","industryVertical":null,"environment":null,"maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{"use":"medical rehab","control":"weight-shift + user intent triggers powered steps","powered":"yes (motor-driven)","runtime":"8 h","weight_kg":25,"regulatory":"FDA cleared","body_region":"lower-limb","availability":"commercial"},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://en.wikipedia.org/wiki/Ekso_Bionics","title":"EksoNR","sourceName":"Wikipedia"},{"url":"https://www.eksobionics.com/","title":"Ekso Bionics (official)","sourceName":"Ekso Bionics (primary)"},{"url":"https://eksobionics.com/eksonr/","title":"EksoNR","sourceName":"Ekso Bionics (official)"},{"url":"https://eksobionics.com/en/eksonr/","title":"EksoNR","sourceName":"Ekso Bionics"},{"url":"https://eksobionics.com/en/indications-for-use/","title":"Indications for Use","sourceName":"Ekso Bionics"}],"aliases":["Ekso NR","Ekso GT"],"collisionRisk":"low","reviewNote":"reverified 2026-06-09 (Kimi-incident remediation): cited primary source resolves and matches manufacturer/reputable domain; relevance adjudicated.","manufacturerTermForTeleop":null,"keyFacts":[{"label":"Type","value":"Exoskeleton for neurorehabilitation"},{"label":"EksoNR clinical rehab exoskeleton (company product page)","value":"Ekso Bionics describes EksoNR as a robotic exoskeleton for rehabilitation settings that enables high-acuity patients to stand and walk, paired with GaitCoach software for real-time gait feedback under therapist control. Treat outcome and dosage claims as company-stated (Ekso Bionics)."},{"label":"FDA-cleared indications and size envelope (company materials)","value":"Ekso Bionics states EksoNR is FDA cleared for stroke, acquired brain injury, MS, and spinal cord injury, fits patients under 220 pounds and between 5' and 6'4\", and is intended for certified rehabilitation centers rather than personal home use. Treat clearance and fit claims as company-stated (Ekso Bionics)."}],"createdAt":"2026-06-06T01:25:39.474Z","updatedAt":"2026-10-09T21:55:39.005Z","unitsInFieldClaimed":null,"unitsInFieldVerified":null,"unitsManufacturedClaimed":null,"unitsManufacturedVerified":null,"unitsAsOf":null,"unitsSource":null,"salesModel":null,"priceUndisclosedSince":null,"autonomyClass":null,"autonomyStatement":null,"autonomyStatementSource":null,"demoForensics":null,"exportControlClass":null,"minCommitment":null,"warrantyTerms":null,"serviceModel":null,"productionRateClaimed":null,"productionRateEvidenced":null,"teleopRatioDisclosed":null,"interventionRateDisclosed":null},"deployment":{"id":"cbb9eca5-f3b7-4400-a536-a8b6c8b973f6","modelId":"a4a2491a-bfdd-4ba3-b370-771d234bc136","versionId":null,"locationId":"aa8b9c05-c836-4021-801f-59801970401e","operatorId":"c36c0cb6-a327-458b-94ec-288386588250","ownerId":null,"slug":"ekso-nr-united-states","status":"operational","firstSeen":"2024-06-01T00:00:00.000Z","statusChangeReason":null,"contractType":null,"pilotOutcome":null,"endedAt":null,"unitsOnSite":null,"tasksPerformed":["autonomous_operation"],"shiftStructure":null,"hoursPerDay":8,"siteType":"facility","operatorConfirmed":false,"humanSupervisionOnsite":null,"locationPrecisionTier":"verified_coordinates","deploymentScale":"large_100_plus","siteEnvironment":"mixed","operatorType":"maker_operated","sourceQualityTier":2,"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://eksobionics.com/en/eksonr/","title":"EksoNR","sourceName":"Ekso Bionics"},{"url":"https://ir.chronoscale.com/press-releases/detail/729/ekso-bionics-receives-fda-clearance-to-market-its-eksonr","title":"Ekso Bionics Receives FDA Clearance for Multiple Sclerosis","sourceName":"ChronoScale"}],"notes":"EksoNR is FDA-cleared for stroke, SCI, acquired brain injury, and multiple sclerosis (first exoskeleton cleared for MS, June 2022). Deployed in 375+ rehabilitation centers worldwide with 200+ published articles. Q1 2026 revenue: Americas $1.55M, EMEA $0.55M, APAC $0.04M. Company disclosed going-concern warning in Q1 2026 10-Q. Pending Business Combination with Applied Digital Cloud (ChronoScale). Go-to-market partners include National Seating & Mobility, Bionic Prosthetics & Orthotics Group, and Ottobock Patient Care.","keyFacts":[{"label":"FDA clearances","value":"Stroke (2016), SCI T4-L5 and C7-T3 ASIA D, ABI (2020), MS (June 2022, K220988), first exoskeleton cleared for MS rehab"},{"label":"Clinical scale","value":"375+ rehabilitation centers worldwide; 200+ published articles; 2,000+ patients across 185+ clinical studies"},{"label":"Americas revenue Q1 2026","value":"$1.55M (US $1.53M)"},{"label":"Going concern","value":"Q1 2026 10-Q discloses substantial doubt; cash funds operations into early Q3 2026; Business Combination with Applied Digital Cloud pending"},{"label":"Go-to-market partners","value":"National Seating & Mobility, Bionic Prosthetics & Orthotics Group, Ottobock Patient Care"}],"reviewNote":null,"exposureHours":null,"deploymentMilesEstimate":null,"exposureBasis":null,"customerSegment":"research","scaleTier":"mass_100_999","contractValueUsd":null,"contractValueBasis":null,"customerCompanyId":null,"customerExternalName":null,"createdAt":"2026-06-07T13:21:38.775Z","updatedAt":"2026-10-09T22:01:38.364Z"},"company":{"id":"c36c0cb6-a327-458b-94ec-288386588250","name":"Ekso Bionics","slug":"ekso-bionics","description":"American [Exoskeleton](/companies/exoskeleton-technologies) company developing powered bionic suits for industrial, medical, and military applications. Publicly traded (NASDAQ: EKSO). Cloud merger approved by principal stockholders.","status":"public","founded":2005,"hq":"Richmond, California, USA","hqLat":37.9357576,"hqLng":-122.347748,"hqGeocodedAt":"2026-08-05T14:27:59.210Z","hqAddress":null,"hqPrecision":null,"website":"eksobionics.com","fundingTotal":null,"type":"hardware","roles":["robot_maker","robot_operator"],"reviewStatus":"reviewed","heatIndex":50,"lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://en.wikipedia.org/wiki/Ekso_Bionics","title":"Ekso Bionics","sourceName":"Wikipedia"},{"url":"https://www.eksobionics.com/","title":"Ekso Bionics (official)","sourceName":"Ekso Bionics (primary)"}],"keyFacts":[{"label":"CEO","value":"Steven Sherman (CEO)"},{"label":"HQ","value":"Richmond, California, USA"},{"label":"Founded","value":"2005"},{"label":"Stock","value":"NASDAQ: EKSO (merger with Cloud approved)"},{"label":"Revenue","value":"~$18.2M"},{"label":"Products","value":"EksoVest (industrial), EksoNR (neurorehabilitation), exoskeleton suits for medical/industrial/military"},{"label":"Incidents","value":"None found, audited"}],"aliases":["Ekso","Ekso Bionics Holdings","Ekso Bionics","Ekso Indego","Ekso GT"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":"EKSO","stockExchange":"NASDAQ","secCik":null,"revenueUsd":null,"revenueBasis":null,"revenueAsOf":null,"employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-06-06T01:25:37.654Z","updatedAt":"2026-10-09T21:30:12.341Z"},"derived":{"status":"active"},"sources":[{"id":"ca153981-7bad-45de-b38d-676a45e6bf9e","incidentId":"c08f2677-3ea3-4488-b3ab-2b47d449cee0","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm","label":null,"publishedAt":null,"notes":null,"title":"FDA MAUDE: Ekso Bionics EksoGT lower back pain","sourceName":"FDA MAUDE","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-08-09T05:28:39.298Z","updatedAt":"2026-08-09T05:28:39.298Z"},{"id":"1dce9792-8066-4a4a-b5e7-64540d091450","incidentId":"c08f2677-3ea3-4488-b3ab-2b47d449cee0","url":"https://eksobionics.com/","label":null,"publishedAt":null,"notes":null,"title":"Ekso Bionics EksoGT safety information","sourceName":"Ekso Bionics","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-08-09T05:30:06.590Z","updatedAt":"2026-08-09T05:30:06.590Z"}],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/ekso-eksogt-lower-back-pain-maude-2020","url":"https://registry.deploy.report/incidents/ekso-eksogt-lower-back-pain-maude-2020","headline":"Ekso Bionics EksoGT: lower-back pain on sit-to-stand in a patient with an incompletely healed femur (FDA MAUDE)","description":"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.","identifier":"c08f2677-3ea3-4488-b3ab-2b47d449cee0","datePublished":"2020-10-28T00:00:00.000Z","articleSection":"injury","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"verified","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":2,"primary_source_types":["primary-fda-database"]}}}