N/A 10016NBRecalls & reported problems
Microport Navibot International LLC · Navigation Trolley Assembly · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850030914002), received between May 22, 2025 and Jun 13, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Off-Label Use” (2 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Off-Label Use2
- Difficult or Delayed Positioning1
Patient problems
- Bone Notching2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning
ALLEGEDLY, SKYWALKER NUMBER REF REF10016-NB, SN (B)(6) WOULD NOT LOCK INTO THE TIBIA DURING THE CUTTING SEQUENCE WITH MOTION FOLLOW, SURGEON CONVERTED TO MANUAL CASE AND CANCELLED THE FOLLOWING TWO CASES TO USE THE ROBOT.
Patient problems: Insufficient Information
MAUDE report 22207406 ↗InjuryMay 22, 2025Off-Label Use; Off-Label Use
ALLEGEDLY, REP WAS NOTIFIED BY THE SURGEON ON (B)(6) 2025 OF SECOND ANTERIOR FEMORAL NOTCHING SEEN ON POST-OP X-RAYS. THE PROCEDURE WAS DONE USING THE SKYWALKER ROBOT WITH EVO MEDIAL-PIVOT KNEE IMPLANTS. THE ROBOTIC SURGICAL PLAN SHOWED AVOIDANCE OF ANTERIOR FEMORAL NOTCHING.
Patient problems: Bone Notching
MAUDE report 22074631 ↗InjuryMay 22, 2025Off-Label Use; Off-Label Use
ALLEGEDLY, ON (B)(6) 2025 OF ANTERIOR FEMORAL NOTCHING SEEN ON POST-OP XRAYS. THE PROCEDURE WAS DONE USING THE SKYWALKER ROBOT WITH EVO MEDIAL-PIVOT KNEE IMPLANTS. THE ROBOTIC SURGICAL PLAN SHOWED AVOIDANCE OF ANTERIOR FEMORAL NOTCHING.
Patient problems: Bone Notching
MAUDE report 22073960 ↗
Other Orthopedic Stereotaxic Instrument devices
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- NA 209063Mako Surgical Corp. · Orthopedic stereotaxic instrument2 recalls602 reports
- RESTORIS, RIO 212760Mako Surgical Corp. · Orthopedic stereotaxic instrument605 reports
- REAL INTELLIGENCE ROB10013Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall528 reports
- VELYS 4515-70-105Depuy (Ireland) · Orthopedic stereotaxic instrument578 reports
- VELYS 4515-70-106Depuy (Ireland) · Orthopedic stereotaxic instrument564 reports
- NA 209999Mako Surgical Corp. · Orthopedic stereotaxic instrument522 reports
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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