Cortium Universal OCT Spinal Fixation System UU071-20-4525Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814386026819), received between Dec 11, 2024 and Dec 12, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Damaged Thread” (2 reports).

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

• InjuryDec 12, 2024Damaged Thread; Damaged Thread

  THE SURGEON PUT ON A CONNECTOR THAT WAS LATERAL AND SHORT. THE SURGEON THEN NOTICED THE T2 SCREW WAS A LITTLE LATERAL AND NOT ALIGNED PROPERLY. HE PROCEEDED AND PUT THE SET SCREW INTO TO THE CONNECTOR AND TIGHTENED THE FIRST SET SCREW OF THE CONNECTOR TO THE ROD AND HAD NO ISSUES. HE THEN WENT TO TIGHTEN THE SET SCREW TO THE TULIP AND NOTICED IT WAS NOT GOING IN RIGHT. UPON FINAL TIGHTENING HE HEARD A POP, AND THE TULIP SPLAYED AND ONE SIDE THE SET SCREW POPPED OUT OF A THREAD. THEY BACKED THE SCREW OUT AGAIN, THEN REMOVED THE PEDICLE SCREW AND SWITCHED IT OUT WITH A NEW ONE WITHOUT REALIGNING. THE SURGEON LOOSENED THE LATERAL CONNECTOR TO RELIEVE THE FORCES ON THE ONE SIDE OF THE SECOND PEDICLE SCREW WHICH REPLACED THE FIRST SCREW, AND IT SPLAYED AGAIN. THEY THEN REMOVED THE SECOND SCREW THAT HAD ALSO SPLAYED DUE TO THE MISALIGNMENT AND REPLACED IT WITH A THIRD SCREW, BUT THIS TIME ADJUSTED IT TO LINE UP BETTER WITH THE ROD AND CONNECTOR, THEN IT LOCKED DOWN. THE SCREW DID NOT SPLAY THIS TIME AS THE ALIGNMENT WAS CORRECT. THE PATIENT WAS NOT AFFECTED, AND THE CASE WENT FINE OTHERWISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912746 ↗
• InjuryDec 11, 2024Damaged Thread; Damaged Thread

  THE SURGEON PUT ON A CONNECTOR THAT WAS LATERAL AND SHORT. THE SURGEON THEN NOTICED THE T2 SCREW WAS A LITTLE LATERAL AND NOT ALIGNED PROPERLY. HE PROCEEDED AND PUT THE SET SCREW INTO TO THE CONNECTOR AND TIGHTENED THE FIRST SET SCREW OF THE CONNECTOR TO THE ROD AND HAD NO ISSUES. HE THEN WENT TO TIGHTEN THE SET SCREW TO THE TULIP AND NOTICED IT WAS NOT GOING IN RIGHT. UPON FINAL TIGHTENING HE HEARD A POP, AND THE TULIP SPLAYED AND ONE SIDE THE SET SCREW POPPED OUT OF A THREAD. THEY BACKED THE SCREW OUT AGAIN, THEN REMOVED THE PEDICLE SCREW AND SWITCHED IT OUT WITH A NEW ONE WITHOUT REALIGNING. THE SURGEON LOOSENED THE LATERAL CONNECTOR TO RELIEVE THE FORCES ON THE ONE SIDE OF THE SECOND PEDICLE SCREW WHICH REPLACED THE FIRST SCREW, AND IT SPLAYED AGAIN. THEY THEN REMOVED THE SECOND SCREW THAT HAD ALSO SPLAYED DUE TO THE MISALIGNMENT AND REPLACED IT WITH A THIRD SCREW, BUT THIS TIME ADJUSTED IT TO LINE UP BETTER WITH THE ROD AND CONNECTOR, THEN IT LOCKED DOWN. THE SCREW DID NOT SPLAY THIS TIME AS THE ALIGNMENT WAS CORRECT. THE PATIENT WAS NOT AFFECTED, AND THE CASE WENT FINE OTHERWISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20909008 ↗