N/A 6067.0050Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00889095167948), received between Sep 23, 2020 and Mar 3, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Fracture

  IT WAS REPORTED THAT EXTENSION ATTEMPT OF PREVIOUS 3-LEVEL CONSTRUCT (6 SCREWS TOTAL). THE FIRST 4 LOCKING CAPS WERE REMOVED AT EASE WITH PART NUMBER 6067.0055. THE 5TH LOCKING CAP POSED AN ISSUE & ULTIMATELY, PART NUMBER 6067.0055 SHEARED & BROKE OFF, LEAVING THE TIP OF THE SHAFT TO BE STUCK WITHIN THE LOCKING CAP & TULIP. MOVING ON TO THE 6TH LOCKING CAP, THE SURGEON ATTEMPTED TO USE PART NUMBER 6067.0050 TO REMOVE THE FINAL SET SCREW. ONCE MORE, THE TIP OF THE SHAFT SHEARED, RESULTING IN THE TIP BEING LEFT WITHIN THE LOCKING CAP & TULIP. THIS WAS A CREO THREADED SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24499689 ↗
• InjuryFeb 18, 2026Fracture

  IT WAS REPORTED ON (B)(6) 2025 THE PATIENT UNDERWENT A SPINAL PROCEDURE TO FIX L2/3/4 USING CREO. ON (B)(6) 2026, THE BONE FUSION WAS COMPLETE, SO THE REMOVAL SURGERY WAS PERFORMED. INTRAOPERATIVELY, WHEN THE SURGEON ATTEMPTED TO LOOSEN A LOCKING CAP AT RIGHT L2, THE TIP OF DRIVER FRACTURED. THE SURGEON COMMENTED THAT SOME FRAGMENTS MAY REMAIN INSIDE THE PATIENT BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24380507 ↗
• 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 22398078 ↗
• MalfunctionAug 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AIS REVISION CASE, AT THE BEGINNING STAGE, THE SURGEON HAD TO REMOVE ALL THE LOCKING CAP TO TAKE THE ROD OUT FOR REPOSITIONING THE SCREWS. HE DAMAGED ONE SCREWDRIVER SHAFT, THE TIP OF THE DRIVER WAS TORN AND FRAGMENTED. THIS EVENT TOOK PLACE IN (B)(6).

  Patient problems: Insufficient Information

  MAUDE report 19928988 ↗
• MalfunctionMay 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGERY THAT THE TIP OF THE DRIVER WAS BROKEN INTO MULTIPLE PIECES, AND PARTS MAY BE LEFT IN THE PATIENT POST OPERATIVELY.

  Patient problems: Spinal Column Injury

  MAUDE report 19309758 ↗
• MalfunctionMar 5, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE TIP OF A CREO DRIVER SHAFT BROKE AND WAS LEFT IN THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 18837791 ↗
• MalfunctionMar 4, 2024Device Handling Problem; Device Handling Problem

  THE TIP OF THE DRIVER SHAFT BROKE WHEN THE SURGEON APPLIED AN OVER TORQUE WHEN SECURING A LOCKING CAP. THE SURGEON WAS UNABLE TO RETRIEVE THE TIP FROM THE LOCKING CAP AND IT REMAINS IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18825378 ↗
• MalfunctionMar 4, 2024Fracture; Fracture

  THE TIP OF THE SCREWDRIVER FRACTURED ON THE FINAL TORQUE OF THE SET SCREW. THE DRIVER MAY NOT HAVE BEEN FULLY SEATED IN THE LOCKING CAP.

  Patient problems: Failure of Implant

  MAUDE report 18825369 ↗
• MalfunctionMar 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A ROUTINE REVISION SURGERY A CREO DRIVER THE DRIVER SHAFT BROKE AND PARTS MAY REMAIN IN THE PATIENT. THIS EVENT OCCURRED IN JAPAN.

  Patient problems: Insufficient Information

  MAUDE report 18817693 ↗
• MalfunctionMar 2, 2023Detachment of Device or Device Component

  THE THREADED PORTION OF ROD SHEARED OFF IN THE IMPLANT. THE THREADS WERE NOT RECOVERABLE, AND WERE LEFT IN THE IMPLANT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16468388 ↗
• MalfunctionFeb 24, 2023Break; Entrapment of Device

  IT WAS REPORTED THAT DURING SURGERY THE TIP OF THE INSTRUMENT WAS BROKEN AND LEFT IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16438414 ↗
• MalfunctionApr 19, 2021Break; Entrapment of Device

  IT WAS REPORTED BY A REPRESENTATIVE FROM JAPAN THAT A REVISION SURGERY WAS DONE TO REMOVE A SPACER DUE TO PATIENT PAIN. DURING THE SURGERY, THE DRIVER TIP BROKE AND REMAINS IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 11689131 ↗
• MalfunctionFeb 12, 2021Break

  IT WAS REPORTED BY A REPRESENTATIVE FROM JAPAN THAT A REVISION SURGERY WAS DONE TO REMOVE A SCREW AND LOCKING CAP WHERE THE DRIVER TIP HAD BROKEN OFF AND WAS LEFT INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11323773 ↗
• MalfunctionOct 19, 2020Break

  IT WAS REPORTED THAT THE DRIVER TIP BROKE OFF IN THE SCREW HEAD AND REMAINS IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10701409 ↗
• MalfunctionSep 23, 2020Break

  IT WAS REPORTED THAT THE TIP OF THE DRIVER SHAFT BROKE AND REMAINS IN THE SCREW WITHIN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 10575541 ↗