{"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":"unreviewed","modelId":"63feef63-412c-4520-93b6-8ffa1a826c6b","deploymentId":null,"companyId":"6502bb45-7c3f-4e3b-ad1f-5c0fe1738696","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,"createdAt":"2026-07-04T04:39:58.885Z","updatedAt":"2026-07-04T04:39:58.885Z","model":{"id":"63feef63-412c-4520-93b6-8ffa1a826c6b","companyId":"6502bb45-7c3f-4e3b-ad1f-5c0fe1738696","modelName":"Yomi S","slug":"yomi-s","description":"Yomi S is the next-generation FDA-cleared robot-assisted dental surgery system from Neocis, featuring AI-guided navigation through the entire implant planning, imaging, and surgical process. It is the successor to the original Yomi system, the first FDA-cleared robotic dental surgery platform.","formFactor":"surgical","maturityStage":"production","lifecycleState":"active","supersededByModelId":null,"specs":{},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.neocis.com/news/neocis-unveils-next-generation-ai-powered-robotic-system-for-dental-implants/","title":"Neocis Unveils Next-Generation AI-Powered Robotic System","sourceName":"Neocis"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[],"createdAt":"2026-07-04T04:39:55.980Z","updatedAt":"2026-07-04T04:40:14.695Z"},"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","fundingTotal":"22000000","type":"hardware","reviewStatus":"reviewed","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,"createdAt":"2026-06-24T05:33:59.780Z","updatedAt":"2026-07-04T04:40:14.545Z"},"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":"unreviewed","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"]}}}