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FIREBIRD 51-2450Recalls & reported problems

Orthofix US LLC · 450mm Rod, CoCr · 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 18257200014453), received between May 18, 2018 and May 18, 2018 — 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 Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 18, 2018Break

    INFORMATION PROVIDED STATES THAT APPROXIMATELY 3 WEEKS POST OP IT WAS NOTICED THAT THE 450MM ROD HAD BROKEN. THE PATIENT IS ASYMPTOMATIC AND A REVISION HAS NOT BEEN PLANNED AT THIS TIME.

    Patient problems: No Code Available

    MAUDE report 7527739 ↗

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