{"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)"}],"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"}],"createdAt":"2026-06-06T01:25:39.474Z","updatedAt":"2026-07-15T13:22:58.127Z","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":"2026-08-21T14:23:30.661Z"},"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 (NASDAQ: EKSO)","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","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":"2026-08-21T22:24:34.156Z"},"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"]}}}