FDA MAUDE report: Yomi guided dental implant robot serious injury event
[INJURY]Jan 1, 2024 · Neocis · Yomi S · San Francisco, California, USA
Failure Mode
INJURY
Event Date
Jan 1, 2024
Primary Entity
Neocis
Robotic Platform
Yomi S
Jurisdiction / Location
San Francisco, California, USA
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=18783685&pc=QRY
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=18783685&pc=QRY
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Details
Incident Context & FAQ
What happened in FDA MAUDE report: Yomi guided dental implant robot serious injury event?
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.
When did this incident occur?
The incident is recorded as occurring on January 1, 2024 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in FDA MAUDE report: Yomi guided dental implant robot serious injury event?
Yomi S by Neocis is the recorded robot involved in this incident at San Francisco, California, USA.
Has anyone responded to FDA MAUDE report: Yomi guided dental implant robot serious injury event?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of FDA MAUDE report: Yomi guided dental implant robot serious injury event?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.