{"id":"30ca7f19-5363-49fc-b145-27020b52e9f2","slug":"injury-2024-01-01-neocis","kind":"injury","headline":"FDA MAUDE report: Yomi guided dental implant robot serious injury event","summary":"An adverse event report was filed in the FDA MAUDE database for the Neocis Yomi Guided Dental Implant Robot, classified as a serious injury. Details are limited in the public MAUDE filing.","occurredAt":"2024-01-01T12:00:00.000Z","reviewStatus":"reviewed","modelId":"59ecd908-5790-40bc-b7f0-e27628adb473","deploymentId":null,"companyId":"6502bb45-7c3f-4e3b-ad1f-5c0fe1738696","dataCenterId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"moderate","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":"none","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":null,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"formFactor":"surgical","latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-07-04T04:39:58.885Z","updatedAt":"2026-07-21T23:41:48.198Z","model":{"id":"59ecd908-5790-40bc-b7f0-e27628adb473","companyId":"6502bb45-7c3f-4e3b-ad1f-5c0fe1738696","modelName":"Yomi S","slug":"neocis-yomi","description":"Yomi (and the upgraded Yomi S) is Neocis's FDA-cleared robotic system for dental-implant surgery, providing haptic guidance with real-time visual/auditory feedback and AI-driven YomiPlan planning to keep instruments on the surgical plan for minimally invasive, often flapless procedures.","formFactor":"surgical","industryVertical":"healthcare","environment":"indoor","maturityStage":"research","lifecycleState":"active","supersededByModelId":null,"specs":{"class":"robotic dental-implant surgery system","guidance":"haptic + AI (YomiPlan)","fda_clearance":"FDA-cleared","visualization":"real-time visual/auditory feedback","clearance_body":"FDA","procedure_types":"dental-implant surgery"},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.neocis.com/","sourceName":"Neocis"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[{"label":"Form factor","value":"surgical"},{"label":"Maker","value":"Neocis"},{"label":"Class","value":"robotic dental-implant surgery system"},{"label":"Guidance","value":"haptic + AI (YomiPlan)"},{"label":"Regulatory status","value":"FDA-cleared"}],"createdAt":"2026-06-24T05:34:01.609Z","updatedAt":"2026-07-12T04:24:54.291Z","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":null,"company":{"id":"6502bb45-7c3f-4e3b-ad1f-5c0fe1738696","name":"Neocis","slug":"neocis","description":"Neocis is a Miami-based surgical robotics company developing [Yomi](/models/yomi-s), the first and only FDA-cleared robot-assisted dental surgery system. Founded by ex-MAKO Surgical engineers, Neocis has received 16 FDA 510(k) clearances and surpassed 100,000 robot-assisted implant placements by 2025. The company's Yomi S platform adds AI-guided navigation to dental implant procedures.","status":"active","founded":2009,"hq":"Miami, FL","hqLat":25.7741566,"hqLng":-80.1935973,"hqGeocodedAt":"2026-08-05T14:40:46.467Z","hqAddress":null,"hqPrecision":null,"website":"neocis.com","fundingTotal":"22000000","type":"hardware","reviewStatus":"reviewed","lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://www.neocis.com/","title":"Neocis Yomi dental robot","date_accessed":"2026-06-23"}],"keyFacts":[{"label":"Robot","value":"Yomi, the first FDA-cleared robotic system for dental-implant surgery"},{"label":"Technology","value":"Uses haptic guidance, real-time feedback, and AI planning (YomiPlan) to constrain instruments to a surgical plan"},{"label":"Scale","value":"Has assisted in placing nearly 100,000 implants"},{"label":"Stage","value":"Private company"},{"label":"CEO","value":"Alon Mozes"},{"label":"FDA Clearances","value":"16 510(k) clearances"},{"label":"Milestone","value":"100,000 implants placed (2025)"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":null,"stockExchange":null,"secCik":null,"revenueUsd":null,"revenueBasis":null,"revenueAsOf":null,"employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-06-24T05:33:59.780Z","updatedAt":"2026-08-05T14:47:17.239Z"},"derived":{"status":"active"},"sources":[{"id":"49c63357-fe66-4eba-9d9b-614bda231ced","incidentId":"30ca7f19-5363-49fc-b145-27020b52e9f2","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=18783685&pc=QRY","label":null,"publishedAt":null,"notes":null,"title":"MAUDE Adverse Event Report: NEOCIS INC YOMI GUIDED DENTAL IMPLANT ROBOT","sourceName":"FDA MAUDE Database","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-04T04:39:59.042Z","updatedAt":"2026-07-04T04:39:59.042Z"}],"responses":[],"statusEvents":[{"id":"bea3c9b2-8909-4cc5-a3ae-cf0f1c7c6da8","incidentId":"30ca7f19-5363-49fc-b145-27020b52e9f2","status":"active","reason":null,"source":"agent:depth","effectiveAt":"2026-07-04T04:39:59.203Z","createdAt":"2026-07-04T04:39:59.204Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/injury-2024-01-01-neocis","url":"https://registry.deploy.report/incidents/injury-2024-01-01-neocis","headline":"FDA MAUDE report: Yomi guided dental implant robot serious injury event","description":"An adverse event report was filed in the FDA MAUDE database for the Neocis Yomi Guided Dental Implant Robot, classified as a serious injury. Details are limited in the public MAUDE filing.","identifier":"30ca7f19-5363-49fc-b145-27020b52e9f2","datePublished":"2024-01-01T12:00:00.000Z","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":1,"primary_source_types":["primary-fda-database"]}}}