UNIVERSAL NAVIGATION EXPEDIUM 2797-02-401NRecalls & reported problems
Medos International Sàrl · UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM AWL TIP TAP 4.35MM · Class 2
Data updated Oct 18, 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 10705034531694), received between Jan 10, 2025 and Jan 10, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Entrapment of Device1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION ON (B)(6) 2024. THE RESIDENT WAS USING THE TAP TO TAP THE PEDICLE. WHEN THEY WENT TO REMOVE THE TAP, IT BROKE OFF INSIDE THE BONE. THE DOCTOR THEN TRIED TO RETRIEVE THE PIECE BUT WAS UNABLE TO DO SO. AFTER SOME DELIBERATION, SURGEON DECIDED TO LEAVE IT IN. THERE WAS A SURGICAL DELAY OF TWENTY-FIVE MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICAL OUTCOME EXPERIENCED BY THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 21124466 ↗
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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