N/A 6067.0055Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889095167955), received between Mar 4, 2021 and Feb 10, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE USING CREO. PATIENT RECEIVED A REVISION SURGERY DUE TO LOOSENING CREO SCREWAT TH12. WHEN THE SURGEON ATTEMPTED TO LOOSEN THE LOCKING CAP ON TH12 USING THE DRIVER, THE DRIVER TIP BROKE. THE BROKEN TIP WAS REMOVED ALONG WITH THE LOCKING CAP AND CREO SCREW. THE SURGEON INSERTED NEW SCREWS INTO TH12 AND TH11. THE FINAL FIXATION AREA WAS TH11/S. IT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307472 ↗
• MalfunctionJan 23, 2026Fracture

  IT WAS REPORTED THAT THE TIP EMBEDDED IN SET SCREW WHILE TRYING TO REMOVE SET SCREW. THE TIP WAS NOT RETRIEVED AND REMAINS IN PATIENT. THERE WAS NOTHING PLACED OVER THE TIP TO PREVENT MIGRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160580 ↗
• MalfunctionDec 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE DRIVER TIP BROKE OFF DURING FINAL TIGHTENING. THE TIP WAS COLD WELDED INTO THE SET SCREW AND COULD NOT BE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877578 ↗
• MalfunctionJul 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION WAS NEEDED TO REMOVE CREO HARDWARE HAVING TO REMOVED.

  Patient problems: Spinal Column Injury

  MAUDE report 22398211 ↗
• MalfunctionMar 5, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING SURGERY THE TIP OF THE DRIVER SHAFT BROKE OFF AND WAS LEFT IN THE SET SCREW.

  Patient problems: Spinal Column Injury

  MAUDE report 18837894 ↗
• MalfunctionMar 4, 2024Fracture; Fracture

  DURING FINAL TIGHTENING, THE DRIVER TIP BROKE OFF IN THE SET SCREW. THE SET SCREW WAS THEN SEALED INTO THE TULIP, WITH THE DRIVER TIP SEALING THE SET SCREW LEAVING NO WAY TO REMOVE OR REVISE.

  Patient problems: Failure of Implant

  MAUDE report 18826247 ↗
• MalfunctionFeb 28, 2022Break

  IT WAS REPORTED THAT THE TIP OF THE CREO DRIVER SHAFT BROKE OFF DURING FINAL TIGHTENING AND WAS LEFT IN THE LOCKING CAP.

  Patient problems: Foreign Body In Patient

  MAUDE report 13623933 ↗
• MalfunctionMar 4, 2021Break

  IT WAS REPORTED BY A REPRESENTATIVE FROM THE (B)(6) THAT A CREO DRIVER TIP BROKE OFF IN THE SCREW HEAD AND REMAINS IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11417715 ↗