YomiLink Bone (UL) DRW-1356-01Recalls & reported problems
Neocis Inc · YomiLink Bone (UL) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810004900486), received between Jun 16, 2023 and Jun 16, 2023 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
WHEN PLACING YOMI LINK BONE (WITHOUT ROBOTIC GUIDANCE), ONE OF THE SCREWS PENETRATED A TOOTH ROOT. THE TOOTH HAD BEEN ALREADY PLANNED TO BE EXTRACTED BUT THIS EVEN IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17144055 ↗
Other Dental Stereotaxic Instrument devices
- Neocis Guidance System DRW-1000-00Neocis Inc · Dental Stereotaxic Instrument81 reports
- X-Guide P010673Xnav Technologies LLC · Dental Stereotaxic Instrument1 recall1 report
- X-GUIDE P010727Xnav Technologies LLC · Dental Stereotaxic Instrument1 recall0 reports
- X-GUIDE P010701Xnav Technologies LLC · Dental Stereotaxic Instrument1 recall0 reports
- YomiLink Teeth Posterior (LRUL) DRW-2081-02Neocis Inc · Dental Stereotaxic Instrument1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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