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CENTURION 69-1072Recalls & reported problems

Orthofix US LLC · ROD REDUCER · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18257200094097), received between Aug 28, 2015 and Aug 28, 2015 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

Most reported problems

Device problems

  • Device Operates Differently Than Expected1
  • Fitting Problem1

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 28, 2015Device Operates Differently Than Expected

    INFORMATION PROVIDED STATES THAT DURING THE PROCEDURE, THE DRILL BITS ARE WEAK AND FLEXIBLE CAUSING THE BITS TO SLIDE OFF THE LATERAL MASS RESULTING IN A DELAY IN THE SURGERY. NO ADVERSE EFFECTS TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5040379 ↗
  • MalfunctionAug 28, 2015Fitting Problem

    INFORMATION PROVIDED STATES THAT DURING THE PROCEDURE, THE PURSUADER (ROD REDUCER) WOULD NOT SEAT ON THE CENTURION SCREWS RESULTING IN A DELAY IN THE SURGERY. NO ADVERSE EFFECTS TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5040308 ↗

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Sources and updates

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