AS Columbus® REVISION NR584ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963988708), received between May 7, 2021 and May 7, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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

Recent adverse event reports

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

• MalfunctionMay 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED TO AESCULAP INC. THAT AN AS COLUMBUS REV FEM.SPACER POST.F4 15MM (PART # NR584Z) WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, BLACK DEBRIS WAS OBSERVED ON THE IMPLANT AS WELL AS INSIDE THE STERILE PACKAGING. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THIS MALFUNCTION PROLONGED THE SURGERY FOR 5-10 MINUTES. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794119 ↗