CREO 5119.1647Recalls & reported problems
Globus Medical, Inc. · CREO® Threaded 6.5 x 45mm Polyaxial Screw · Class 2
All models of CREO (100)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889095104158), received between Dec 7, 2020 and Mar 14, 2025 — classified as 2 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information3
- Use of Device Problem2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Fracture1
- Loss of or Failure to Bond1
- Mechanical Problem1
Patient problems
- Insufficient Information8
- Complaint, Ill-Defined1
- Spinal Column Injury1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2025Fracture; Fracture
IT WAS REPORTED THAT A CREO THREADED SCREW WAS FOUND BROKEN POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Insufficient Information
MAUDE report 21609552 ↗MalfunctionMar 5, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED DUE TO CREO THREADED 6.5X45MM POLYAXIAL SCREWS THAT WERE FOUND LOOSE POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Insufficient Information
MAUDE report 18838035 ↗MalfunctionMar 5, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THERE WAS A REVISION TO REPLACE CREO THREADED SCREWS THAT WERE FOUND LOOSE POST OPERATIVELY WITH SUBSEQUENT SPACER MIGRATION. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Insufficient Information
MAUDE report 18834180 ↗MalfunctionMar 4, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO A LOOSENED SCREW WHICH SHOWED HALOING.
Patient problems: Spinal Column Injury
MAUDE report 18830965 ↗InjuryMar 4, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT POST-OPERATIVE IMAGING SHOWED THAT THE LEFT L4 AND S1 PEDICLE SCREWS WERE NOT PLACED PROPERLY. REVISION SURGERY WAS PERFORMED TO REPOSITION.
Patient problems: Insufficient Information
MAUDE report 18827140 ↗MalfunctionMar 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED A CREO ROD BECAME LOOSE TWENTY-THREE DAYS POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18823395 ↗MalfunctionMar 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED A CREO SCREW HAD BEEN PLACED MEDIALLY AND THE PATIENT WAS EXPERIENCING PAIN POST-OPERATIVELY. ADDITIONALLY, CREO SCREWS HAD LOOSENED DUE TO POOR BONE QUALITY.
Patient problems: Insufficient Information
MAUDE report 18823381 ↗MalfunctionFeb 29, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A MAGINIFY-S SPACER WITH HA COATED SCREWS WERE PLACED ANTERIORLY. THE PATIENT WAS THEN FLIPPED TO PLACE THE CREO PEDICLE SCREWS POSTERIORLY AND WHILE INSERTING ONE SCREW, IT SUBSEQUENTLY PUSHED OUT ONE OF THE SCREWS SECURING THE SPACER.
Patient problems: Insufficient Information
MAUDE report 18810323 ↗MalfunctionFeb 22, 2021Break
IT WAS REPORTED BY A REPRESENTATIVE FROM BELGIUM THAT A REVISION SURGERY WAS DONE DUE TO A SCREW WHICH HAD BROKEN 6 WEEKS POST-OPERATIVELY WITH LOSS OF COMPRESSION AND PUSH BACK OF 1 OF THE SUSTAIN CAGES.
Patient problems: Insufficient Information
MAUDE report 11362285 ↗InjuryDec 7, 2020Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED BY A REPRESENTATIVE FROM (B)(6) THAT A REVISION SURGERY WAS DONE TO REPLACE 2 OF 3 SCREWS WHICH HAD DEVIATED POST-OPERATIVELY CAUSING ADVERSE EFFECTS TO THE PATIENT.
Patient problems: Complaint, Ill-Defined
MAUDE report 10962609 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
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- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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