{"id":"0682f2d6-4c13-4d6a-86ee-2506a05b824b","slug":"lifeward-rewalk-personal6-tibial-plateau-fracture-maude-2019","kind":"injury","headline":"ReWalk (now Lifeward) Personal 6.0: lateral tibial plateau fracture in a new user (FDA MAUDE)","summary":"An FDA MAUDE injury report describes a new user of the ReWalk Personal 6.0 powered exoskeleton sustaining a lateral tibial plateau fracture. ReWalk Robotics rebranded to Lifeward in 2024. Distinct from the 2017 ReWalk tibia/fibula recall (a recall, not a MAUDE report). Source: FDA MAUDE MDR key 10050473, accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.","occurredAt":"2019-12-18T00:00:00.000Z","reviewStatus":"reviewed","modelId":"2f847d21-9b21-4ce0-bb03-6d2bd97ae10b","deploymentId":"28a404b5-9f66-4176-bc97-0157d71d22bf","companyId":"4421900a-d71f-407e-a37c-ad1e3905e97f","dataCenterId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"serious","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":"2026-06-27T10:59:26.014Z","updatedAt":"2026-08-09T05:30:14.099Z","model":{"id":"2f847d21-9b21-4ce0-bb03-6d2bd97ae10b","companyId":"4421900a-d71f-407e-a37c-ad1e3905e97f","modelName":"ReWalk 7","slug":"rewalk-7","description":"Powered lower-limb personal exoskeleton; latest ReWalk generation, FDA cleared March 2025. Motor-driven powered gait for spinal-cord-injury users.","formFactor":"exoskeleton","industryVertical":null,"environment":null,"maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{"use":"medical (personal, SCI)","control":"weight-shift triggered powered gait","powered":"yes (motor-driven)","regulatory":"FDA cleared 2025-03","body_region":"lower-limb","availability":"commercial (2025 launch)"},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://ir.golifeward.com/news-releases/news-release-details/fda-issues-clearance-rewalk-7-exoskeleton","title":"ReWalk 7 (FDA clearance 2025)","sourceName":"Lifeward (primary)"},{"url":"https://golifeward.com/","title":"Lifeward (official)","sourceName":"Lifeward (primary)"}],"aliases":["ReWalk 7"],"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 rehabilitation"}],"createdAt":"2026-06-06T01:25:40.609Z","updatedAt":"2026-07-08T20:09:21.124Z","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":"28a404b5-9f66-4176-bc97-0157d71d22bf","modelId":"d59824bf-88ca-4eea-b027-88b11c7fdee3","versionId":null,"locationId":"c1051b93-f4e0-4483-80d0-e67d4737df1f","operatorId":"4421900a-d71f-407e-a37c-ad1e3905e97f","ownerId":null,"slug":"rewalk-personal-6-home-use-us","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":"urban","operatorConfirmed":false,"humanSupervisionOnsite":null,"locationPrecisionTier":"verified_coordinates","deploymentScale":"medium_11_100","siteEnvironment":"outdoor","operatorType":"maker_operated","sourceQualityTier":2,"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://rewalk.com/","title":"ReWalk","date_accessed":"2026-06-07"},{"url":"https://ir.rewalk.com/news-releases/news-release-details/department-veterans-affairs-purchases-20-rewalk-systems-support","title":"Department of Veterans Affairs Purchases 20 ReWalk Systems","retrievedAt":"2026-06-27T12:00:00Z"},{"url":"https://rewalk.com/blog/u-s-department-of-veterans-affairs-expands-access-to-rewalk-exoskeletons-for-paralyzed-veterans-with-revised-national-policy/","title":"U.S. Department of Veterans Affairs Expands Access to ReWalk Exoskeletons","retrievedAt":"2026-06-27T12:00:00Z"}],"notes":"ReWalk Personal 6.0 exoskeleton home-use deployments across US. FDA-cleared for spinal cord injury patients at home and community.","keyFacts":[{"label":"Fleet","value":"ReWalk Personal 6.0 exoskeleton"},{"label":"Coverage","value":"Home-use deployments across US"},{"label":"Use Case","value":"Spinal cord injury patients at home and community"},{"label":"Regulatory","value":"FDA-cleared"}],"reviewNote":null,"exposureHours":null,"deploymentMilesEstimate":null,"exposureBasis":null,"customerSegment":"research","scaleTier":"commercial_10_99","contractValueUsd":null,"contractValueBasis":null,"customerCompanyId":null,"customerExternalName":null,"createdAt":"2026-06-07T22:54:26.859Z","updatedAt":"2026-08-21T14:21:33.821Z"},"company":{"id":"4421900a-d71f-407e-a37c-ad1e3905e97f","name":"Lifeward","slug":"lifeward","description":"Lifeward (formerly [Rewalk robotics](/companies/rewalk-robotics), Nasdaq: LFWD) is an Israeli-American medical device company founded in 2001 by Dr. Amit Goffer, a quadriplegic inventor who developed the exoskeleton after an ATV accident. The company designs and commercializes powered exoskeleton systems for individuals with spinal cord injury, including the ReWalk 7 Personal Exoskeleton (FDA-cleared March 2025) and the ReWalk Personal 6.0. Lifeward's portfolio also includes the AlterG Anti-Gravity System, ReStore Exo-Suit, and MyoCycle FES System, with operations in the US, Israel, and Germany.","status":"public (NASDAQ: LFWD; formerly ReWalk Robotics, RWLK)","founded":2001,"hq":"Marlborough, MA, USA / Yokneam Ilit, Israel","hqLat":null,"hqLng":null,"hqGeocodedAt":"2026-08-05T00:51:10.902Z","hqAddress":null,"hqPrecision":null,"website":"alterg.com","fundingTotal":null,"type":"hardware","roles":["robot_maker","robot_operator"],"reviewStatus":"reviewed","lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://ir.rewalk.com/news-releases/news-release-details/rewalk-robotics-transforms-company-identity-rebrands-lifeward","title":"Lifeward","sourceName":"Lifeward (primary)"},{"url":"https://golifeward.com/blog/rewalk-personal-exoskeleton-system-clearned-fda-home-use/","title":"ReWalk Personal 6.0 FDA home-use","sourceName":"Lifeward (primary)"},{"url":"https://ir.rewalk.com/news-releases/news-release-details/lifeward-names-mark-grant-new-ceo","label":"Lifeward Names Mark Grant as New CEO","title":"Lifeward Names Mark Grant as New CEO","mediaType":"article","sourceName":"Lifeward (official IR)"},{"url":"https://golifeward.com/blog/lifeward-launches-sales-of-the-rewalk-7-personal-exoskeleton-in-u-s-market/","label":"Lifeward Launches Sales of the ReWalk 7 Personal Exoskeleton in U.S. Market","title":"Lifeward Launches Sales of the ReWalk 7 Personal Exoskeleton in U.S. Market","mediaType":"article","sourceName":"Lifeward (official)"},{"url":"https://www.sec.gov/Archives/edgar/data/1607962/000117891325000736/zk2532799.htm","label":"Lifeward Ltd. SEC Filing 2025","title":"Lifeward Ltd. SEC Filing 2025","mediaType":"article","sourceName":"SEC EDGAR"}],"keyFacts":[{"label":"CEO","value":"Mark Grant (since June 2025)"},{"label":"Previous CEO","value":"Larry Jasinski"},{"label":"CFO","value":"Mike Lawless"},{"label":"Founder","value":"Dr. Amit Goffer (deceased) — quadriplegic Israeli inventor"},{"label":"Ticker","value":"NASDAQ: LFWD"},{"label":"Revenue 2024","value":"Approximately 25.3 million USD"},{"label":"Units deployed","value":"131 rehabilitation units + 689 personal exoskeleton units (as of Dec 2024)"},{"label":"FDA clearance","value":"ReWalk 7 cleared March 2025; first FDA-cleared exoskeleton in 2014"},{"label":"Medicare","value":"CMS reimbursement pathway established 2024"},{"label":"Operations","value":"United States, Israel, Germany"},{"label":"Product portfolio","value":"ReWalk 7, ReWalk Personal 6.0, AlterG Anti-Gravity, ReStore Exo-Suit, MyoCycle FES"}],"aliases":["ReWalk Robotics","ReWalk"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":"LFWD","stockExchange":"NASDAQ","secCik":"0001607962","revenueUsd":null,"revenueBasis":null,"revenueAsOf":null,"employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-06-06T01:25:37.810Z","updatedAt":"2026-08-21T22:24:00.932Z"},"derived":{"status":"active"},"sources":[{"id":"e8067227-bc6e-4d3d-a602-2ae41d4c9cbd","incidentId":"0682f2d6-4c13-4d6a-86ee-2506a05b824b","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm","label":null,"publishedAt":null,"notes":null,"title":"FDA MAUDE: ReWalk Personal 6.0 tibial plateau fracture","sourceName":"FDA MAUDE","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-08-09T05:28:40.534Z","updatedAt":"2026-08-09T05:28:40.534Z"},{"id":"217f5dc9-2d58-4a74-a48c-a28005fba733","incidentId":"0682f2d6-4c13-4d6a-86ee-2506a05b824b","url":"https://www.lifeward.com/","label":null,"publishedAt":null,"notes":null,"title":"Lifeward (formerly ReWalk) Personal 6.0 safety information","sourceName":"Lifeward","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-08-09T05:30:08.904Z","updatedAt":"2026-08-09T05:30:08.904Z"},{"id":"2f19c05c-fb34-46a4-90d6-0746433b9dc2","incidentId":"0682f2d6-4c13-4d6a-86ee-2506a05b824b","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7443771&pc=PHL","label":null,"publishedAt":null,"notes":null,"title":"MAUDE Adverse Event Report: REWALK ROBOTICS LTD - ReWalk Personal 6.0 bone fracture, swollen ankle","sourceName":"FDA MAUDE","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-08-09T05:31:47.075Z","updatedAt":"2026-08-09T05:31:47.075Z"}],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/lifeward-rewalk-personal6-tibial-plateau-fracture-maude-2019","url":"https://registry.deploy.report/incidents/lifeward-rewalk-personal6-tibial-plateau-fracture-maude-2019","headline":"ReWalk (now Lifeward) Personal 6.0: lateral tibial plateau fracture in a new user (FDA MAUDE)","description":"An FDA MAUDE injury report describes a new user of the ReWalk Personal 6.0 powered exoskeleton sustaining a lateral tibial plateau fracture. ReWalk Robotics rebranded to Lifeward in 2024. Distinct from the 2017 ReWalk tibia/fibula recall (a recall, not a MAUDE report). Source: FDA MAUDE MDR key 10050473, accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.","identifier":"0682f2d6-4c13-4d6a-86ee-2506a05b824b","datePublished":"2019-12-18T00:00:00.000Z","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":3,"primary_source_types":["primary-fda-database"]}}}