NA 3010-19-021Recalls & reported problems
Medos International Sàrl · NAVIGATION ENABLED INSTRUMENTS DUAL LEAD AWL TIP TAP 4.35MM · Class 2
Data updated Oct 13, 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 10705034561318), received between Aug 31, 2023 and Aug 31, 2023 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
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.
MalfunctionAug 31, 2023Break; Break
IT WAS REPORTED THAT ON (B)(6) 2023, DURING SPINE PROCEDURE(T8-9 FUSION) THE 4.35 AWL TIP TAP WAS BEING USED IN THE CASE AND THE ENTIRE TIP BROKE OFF INSIDE OF THE PATIENT. ADDED SOME TIME TO CASE TRYING TO GET THE PIECE OUT. THEY HAD TO OPEN UNIVERSAL REMOVAL AND THE SHUKLA SET TO FINALLY REMOVE THE BROKEN PIECE, BUT THE PEDICLE WAS DESTROYED. IT INCREASED POTENTIAL RISK OF INFECTION AND THE TIME UNDER ANESTHESIA. THEY ALSO BROKE A REMOVAL DRIVER IN THE PROCESS. MULTIPLE X-RAYS WERE TAKEN TO CONFIRM THE FULL REMOVAL OF THE BROKEN PIECE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 60 MINUTES. THIS REPORT IS FOR ONE (1) 4.35 NAV DUAL LEAD AWL TIP TAP. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17663500 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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