CASCADIA™ Interbody System 6101-2102814NC-G2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888857160613), received between Apr 29, 2021 and Apr 29, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Information” (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 18, 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.

• MalfunctionApr 29, 2021Packaging Problem; Inaccurate Information; Packaging Problem; Inaccurate Information

  A COMPANY REPRESENTATIVE REPORTED THAT A STERILE CASCADIA AN INTERBODY WAS NOTED TO BE THE WRONG SIZE AS IT WAS BEING PREPARED ON THE BACK TABLE DURING SURGERY. FURTHER INVESTIGATION IDENTIFIED THAT THE LABELLING ON THE PACKAGE INDICATED THE DEVICE WAS A 10 X 28 X 14 MM INTERBODY (6101-2102814NC-G2) WHILE THE DEVICE INSIDE THE PACKAGING WAS ACTUALLY A 10 X 22 X 15 MM INTERBODY (6101-2102215NC-G2). THE DIRECT PART MARKING ON THE DEVICE CORRECTLY IDENTIFIED THE DIMENSIONS; THE DISCREPANCY WAS WITH THE LABELS ON THE EXTERIOR PACKAGING AND THE INNER TYVEK SEAL. THE CASE WAS SUCCESSFULLY COMPLETED FOLLOWING A TEN-MINUTE DELAY AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11747102 ↗