ROBOTIC INTEGRATION INSTRUMENTS 2914-89-308Recalls & reported problems
Medos International Sàrl · ROBOTIC INTEGRATION INSTRUMENTS TRIALTIS Driver Guide · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034582146), received between Nov 12, 2025 and Nov 12, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility1
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.
MalfunctionNov 12, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING SPINE SURGERY - T4 TO L4, THE NAVIGATION CAMERA COULD NOT VISUALIZE ROBOTIC ARM DUE TO THE LACK OF AN EXTRA JOINT. THE TRIALTUS SCREWDRIVER LODGED AFTER SCREW RELEASE MODE AND COULD NOT REMOVE THE SCREWDRIVER FROM TULIP HEAD. THE SCREWDRIVER WAS REMOVED USING SLIGHT FORCE. THE L4 LEFT SCREW RELEASE MODE WAS EXCESSIVE DUE TO SOFT TISSUE, THIS CAUSED THE SCREW TO BE LATERAL TO PLAN. FREEHAND NAVIGATION WAS USED TO REPLACE IT. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23534244 ↗
Other Orthopedic stereotaxic instrument devices
- REAL INTELLIGENCE ROB10024Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall924 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.