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NA 286755010NRecalls & reported problems

Medos International Sàrl · UNIVERSAL NAVIGATION CLAMP ATTACHMENT, SMALL · 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 10705034472249), received between Apr 15, 2022 and Apr 15, 2022 — 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.

  • MalfunctionApr 15, 2022Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE UNIVERSAL NAVIGATION CLAMP ATTACHMENT DEVICE BROKE. THERE WERE NO SURGICAL DELAYS REPORTED. NO FRAGMENTS REMAINED IN THE PATIENT. THE PATIENT¿S OUTCOME WAS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE (1) UNAV CLAMP ATTACHMENT, SM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14119521 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.