{"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":"4b3615cc-8184-4fac-9797-f1a960beb7f4","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"},{"label":"Yomi page prints 100,000 implants placed","value":"Neocis's Yomi page prints 100k implants placed with Yomi, about one implant placed robotically every 3.8 minutes, and 43 percent practice growth two years after implementing Yomi from data on file across 30 customer accounts. The page also introduces Yomi S as the current robot. The stored class label is not this volume cell ([Neocis Yomi](https://www.neocis.com/))."},{"label":"Yomi page prints first and only FDA-cleared dental robot","value":"The same page says Yomi is the first and only FDA-cleared robot-assisted dental surgery system, intended for partially and fully edentulous adult patients, with planning software and intraoperative navigational guidance. That clearance wording is not the stored regulatory label ([Neocis Yomi](https://www.neocis.com/))."}],"createdAt":"2026-06-24T05:34:01.609Z","updatedAt":"2026-10-03T21:17:45.730Z","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":"4b3615cc-8184-4fac-9797-f1a960beb7f4","modelId":"63feef63-412c-4520-93b6-8ffa1a826c6b","versionId":null,"locationId":"d7490c29-550f-4089-9de3-17d44a1ade69","operatorId":"6502bb45-7c3f-4e3b-ad1f-5c0fe1738696","ownerId":null,"slug":"yomi-s-san-francisco-california-usa","status":"operational","firstSeen":"2023-01-01T00:00:00.000Z","statusChangeReason":null,"contractType":null,"pilotOutcome":null,"endedAt":null,"unitsOnSite":null,"tasksPerformed":["surgical_assistance"],"shiftStructure":null,"hoursPerDay":8,"siteType":"hospital","operatorConfirmed":null,"humanSupervisionOnsite":null,"locationPrecisionTier":"city_centroid","deploymentScale":"medium_11_100","siteEnvironment":"indoor","operatorType":null,"sourceQualityTier":2,"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.neocis.com/","name":"Neocis","title":"Neocis: Yomi Dental Robot - Next Gen Dental Implant Surgery"}],"notes":"Bay Area Surgical Arts in California is listed as a Yomi provider on the Neocis website.","keyFacts":[],"reviewNote":null,"exposureHours":null,"deploymentMilesEstimate":null,"exposureBasis":null,"customerSegment":"healthcare","scaleTier":"commercial_10_99","contractValueUsd":null,"contractValueBasis":null,"customerCompanyId":null,"customerExternalName":null,"createdAt":"2026-08-08T22:32:35.629Z","updatedAt":"2026-08-21T14:22:07.739Z"},"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","roles":["robot_maker","robot_operator"],"reviewStatus":"reviewed","heatIndex":83,"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":"2026-08-21T22:21:13.629Z"},"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"]}}}