{"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)"},{"url":"https://golifeward.com/blog/fda-issues-clearance-for-rewalk-7-exoskeleton/","date":"2025-03-13","title":"FDA Issues Clearance for ReWalk 7 Exoskeleton","sourceName":"Lifeward"},{"url":"https://golifeward.com/products/rewalkpersonal-exoskeleton/","title":"ReWalk 7 personal exoskeleton","sourceName":"Lifeward"}],"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"},{"label":"FDA 510(k) clearance (primary Lifeward)","value":"Lifeward (Nasdaq: LFWD) announced on March 13 2025 that it received 510(k) FDA clearance for ReWalk 7, which it calls the seventh generation of its personal exoskeleton for people with spinal cord injury to stand and walk. CEO Larry Jasinski is quoted. The company said U.S. sales would begin as soon as the product is available, so clearance is not the same as a shipped census ([Lifeward](https://golifeward.com/blog/fda-issues-clearance-for-rewalk-7-exoskeleton/))","sourceUrl":"https://golifeward.com/blog/fda-issues-clearance-for-rewalk-7-exoskeleton/"},{"label":"Prior clearances cited by Lifeward","value":"The same release says the FDA cleared ReWalk 6.0 for stairs and curbs in 2023, that CMS issued a national reimbursement policy in 2024 for beneficiaries who qualify, and that the company received what it calls the nation's first FDA clearance for an exoskeleton medical device for individuals with SCI in 2014. Treat the 'first' claim as company-stated history ([Lifeward](https://golifeward.com/blog/fda-issues-clearance-for-rewalk-7-exoskeleton/))","sourceUrl":"https://golifeward.com/blog/fda-issues-clearance-for-rewalk-7-exoskeleton/"},{"label":"ReWalk 7 page prints T7 to L5 home use and T4 to T6 rehab use","value":"Lifeward's ReWalk 7 page says the US indication is spinal cord injury at T7 to L5 for home and community ambulation with a certified companion, and T4 to T6 for ambulatory functions in rehabilitation institutions. The stored March 2025 clearance sentence is not this level cell ([ReWalk 7](https://golifeward.com/products/rewalkpersonal-exoskeleton/))."},{"label":"ReWalk 7 page prints two customizable walking speeds","value":"The same page says users can select from two customizable walking speeds for indoor and outdoor transitions, and that crutch control lets the user stand, walk, select speeds, and stop from the crutches. Those cells are not the stored ReWalk 6.0 stairs sentence ([ReWalk 7](https://golifeward.com/products/rewalkpersonal-exoskeleton/))."}],"createdAt":"2026-06-06T01:25:40.609Z","updatedAt":"2026-10-04T04:23:58.557Z","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","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","heatIndex":54,"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"]}}}