CREO 6120.5000Recalls & reported problems
Globus Medical, Inc. · Threaded Locking Cap Driver · Class 1
All models of CREO (100)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889095173604), received between Sep 23, 2020 and Apr 7, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture2
- Material Fragmentation2
- Entrapment of Device1
- Loose or Intermittent Connection1
- Material Deformation1
- Mechanical Problem1
Patient problems
- Insufficient Information5
- Failure of Implant2
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2026Fracture
IT WAS REPORTED THAT ON (B)(6) 2025, SURGERY WAS PERFORMED TO EXTEND THE FIXATION AREA FOR THE PATIENT WITH L5/S POSTERIORLY FIXED BY CREO DUE TO INFECTION. THE SURGEON TRIED TO REMOVE THE LOCKING CAP ON THE RIGHT S SUING A DRIVER, BUT IT WOULD NOT COME OFF. AS A RESULT, FOUR DRIVERS WERE USED, BUT ALL OF WHICH BROKE OFF. ONE OF THESE DRIVERS LEFT A BROKEN PIECE INSIDE THE LOCKING CAP. THE BROKEN PIECE COULD NOT BE REMOVED AND REMAINS IN THE LOCKING CAP. THE SURGEON INSERTED SCREWS INTO THE SAI AND CONNECTED THE RODS USING A COMPETITOR'S CONNECTOR.
Patient problems: Foreign Body In Patient
MAUDE report 24802193 ↗MalfunctionMar 5, 2024Fracture; Fracture
IT WAS N:MORTED THAT THE TIO OF THE THREADED LOCKINQ CAP DRIVER BROKE OFF WITHIN THE SET SCREW AND COULD NOT BE RETRIEVED.
Patient problems: Failure of Implant
MAUDE report 18839366 ↗MalfunctionMar 5, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING SURGERY THE DRIVER TIP BROKE WHILE SURGEON WAS IMPLANTING A LOCKING CAP AND IS RETAINED IN THE SCREW HEAD.
Patient problems: Insufficient Information
MAUDE report 18837435 ↗MalfunctionMar 5, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING SURGERY THE TIP OF THE CREO THREADED LOCKING CAP DRIVER WAS BROKEN AND LEFT IN A SET SCREW IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 18834285 ↗MalfunctionMar 4, 2024Material Fragmentation; Material Fragmentation
THE TIP OF A THREADED LOCKING CAP DRIVER BROKE OFF IN THE LOCKING CAP DURING SURGERY. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN TIP AND IT REMAINS IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 18825399 ↗MalfunctionMar 2, 2024Break; Break
IT WAS REPORTED THE DISTAL TIP OF THE DRIVER BROKE OFF WHEN TRYING TO REMOVE THE SET SCREW. THE INSTRUMENT TIP WAS UNABLE TO BE RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 18823390 ↗MalfunctionFeb 29, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SURGEON USED THE CORRECT LOCKING CAP DRIVER TO IMPLANT THE CREO AMP THREADED END CAP. HE PASSED IT THROUGH THE COUNTER TORQUE, INTO THE 20MM REDUCTION TULIPS, AND BEGAN TIGHTENING THE END CAP INTO THE CONSTRUCT. UPON REMOVING THE DRIVER FROM THE INITIAL TIGHTENING HE NOTICED THE TIP OF THE SCREWDRIVER HAD BROKEN OFF IN THE END CAP. SURGEON ATTEMPTED TO REMOVE THE BROKEN PIECE, HOWEVER IT SAT FLUSH INSIDE THE END CAP. NO ADHESIVE OR INSTRUMENT WAS ABLE TO REMOVE IT AND THE BROKEN SCREWDRIVER TIP WAS LEFT WITHIN THE END CAP.
Patient problems: Insufficient Information
MAUDE report 18809726 ↗MalfunctionJun 30, 2022Loose or Intermittent Connection
IT WAS REPORTED THAT A CREO THREADED LOCKING CAP DRIVER TIP BROKE OFF IN THE LOCKING CAP AND REMAINS IN THE PATIENT.
Patient problems: Failure of Implant
MAUDE report 14873597 ↗MalfunctionMay 10, 2021Break
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING PROVISIONAL TIGHTENING, AND REMAINS IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 11802232 ↗MalfunctionSep 23, 2020Entrapment of Device
IT WAS REPORTED THAT THE TIP OF THE THREADED LOCKING CAP DRIVER BROKE OFF IN THE SET SCREW. THE SCREW AND ROD WERE REMOVED AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10575527 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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