N/A 302015100Recalls & reported problems
Medos International Sàrl · UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION ARRAY VIOLET 4 SPHERES · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10705034536217), received between Nov 19, 2024 and Nov 19, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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. 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
- Material Deformation1
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 19, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT ON (B)(6) 2024, WHILE NAVIGATING AN MIS SPINE CASE, T12-L5 TUMOR AT L3, A SCREW, AT T12 LEFT SIDE, ENDED UP IN THE LATERAL MOST PART OF THE SPINAL CANAL ACCORDING TO A LOOP-X 3D SCAN, WHILE ALL OTHER SCREWS, INCLUDING RIGHT T12, WERE IN EXPECTED LOCATIONS. THE SPINOUS PROCESS CLAMP WAS PLACED AT L5 AND THE PATIENT WAS REGISTERED USING LOOP-X AIR. ACCURACY WAS CHECKED WITH THE POINTER AT L5 AND ACCEPTED. THE ONLY NAVIGATED INSTRUMENT USED DURING THIS CASE WAS THE DEPUY SYNTHES VIPER PRIME, WHICH WHEN REGISTERED SHOWED A TIP DEVIATION BETWEEN 0.0-0.2MM AND THE INSTRUMENT ARRAY WAS CONFIRMED TO BE TIGHTLY ON THE INSTRUMENT. THE DOCTOR STARTED AT T12 ON THE RIGHT SIDE, HOWEVER DUE TO THE PATIENT'S DIFFICULT ANATOMY THE DOCTOR HAD A TOUGH TIME GETTING THE SCREW TO TAKE HOLD AND DECIDED TO SWITCH SIDES. BEFORE NAVIGATING THE OTHER SIDE, ACCURACY WAS CHECKED AND FOUND TO BE ACCURATE AT L5. THE LEFT SIDE OF T12 WAS ALSO DIFFICULT BUT THE DOCTOR WAS ABLE TO GET THE SCREW INTO BONE WITH ENOUGH FORCE. THE PATIENT WAS INVOLVED, BUT THERE WAS NO DELAY OF SURGERY AND NO NEGATIVE EFFECTS. LEFT T12 SCREW ENDED UP IN THE SPINAL CANAL, ROUGHLY ONE SCREW OVER MEDIAL TO WHAT WAS P
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20725755 ↗
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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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