CREO 1119.0010Recalls & reported problems
Globus Medical, Inc. · Threaded Locking Cap, CREO · Class 2
All models of CREO (100)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Globus CREO locking cap secures rods in spinal screws. Many of the 80 reports describe caps coming loose, detaching or popping off, and some describe rods breaking or screw heads separating. The reports include 3 injuries and no deaths. Reports rose from 1 in the prior year to 6 in the latest year. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 80
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00889095059496), received between Oct 6, 2020 and Apr 13, 2026 — classified as 3 injuries, 77 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (24 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
- Loose or Intermittent Connection24
- Migration8
- Detachment of Device or Device Component7
- Device Dislodged or Dislocated6
- Appropriate Device Problem Term/Code Not Available5
- Insufficient Device Problem Information5
- Loosening of Implant Not Related to Bone-Ingrowth5
- Break4
Patient problems
- Insufficient Information39
- Failure of Implant14
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- Spinal Column Injury7
- No Clinical Signs, Symptoms or Conditions6
- Unspecified Infection4
- Pain3
- Spinal Cord Injury1
Recent adverse event reports
The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2026Migration
IT WAS REPORTED THAT THE SURGEON REVISED A T8-PELVIS ON (B)(6) 2025 IN WHICH A SET CAP CAME OUT OF THE ILIAC BOLT THAT WAS CONNECTED TO AN ACCESSORY ROD. THE MAIN RODS OF THE CONSTRUCT FRACTURED AND A REVISION WAS REQUIRED. THE SURGEON ADDED 3 TLIFS DURING THE REVISION AND REPLACED THE MAIN RODS AND ACCESSORY RODS. HE ALSO UPSIZED 4X SCREWS OF THE ORIGINAL CONSTRUCT DUE TO HALOING OF THE BONE AROUND THE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865829 ↗MalfunctionFeb 20, 2026Migration
IT WAS REPORTED THAT THERE WAS A REVISION FOR LOOSE SET SCREW AND TULIPS AT L5 RIGHT. RIGHT SIDE OF THE CONSTRUCT WAS REPLACED WITH 2X FRESH 30MM TULIPS AND 2X SET SCREWS. THE POST OP CT SCAN CONFIRMED CORRECT AND LOCKED OFF PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402019 ↗MalfunctionFeb 6, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT THE CREO THREADED SET SCREWS NEEDED TO BE REMOVED DUE TO INFECTION, AND THE SET SCREWS WERE STUCK. WE USED THE CUSTOM INSTRUMENT HEAD PLAYER TO SPLAY THE HEADS AND REMOVE THE SET SCREWS. ALL CREO ONE SCREWS WERE REMOVED, AND SEVERAL, IF NOT ALL, OF THE HEADS WERE LOCKED AND HAD NO POLYAXIAL MOVEMENT. THE ORIGINAL SURGERY WAS ON (B)(6) 2025. THE SCREWS AND SET SCREWS WERE SENT TO THE LAB FOR CULTURING AND WILL BE RETURNED WHEN THAT IS FINISHED.
Patient problems: Unspecified Infection
MAUDE report 24282703 ↗MalfunctionJan 20, 2026Device Slipped
IT WAS REPORTED THAT THE CREO SCREW HEAD SOMEHOW SEPARATED FROM THE CONSTRUCT, RESULTING IN A REVISION SURGERY EXTENSION OF A PREVIOUS FUSION.
Patient problems: Insufficient Information
MAUDE report 24121618 ↗MalfunctionJan 12, 2026Migration
IT WAS REPORTED THAT THE CREO THREADED SET SCREWS POPPED OFF OF TULIPS MONTHS LATER. WE WILL BE GOING BACK AND REVISING THE PATIENTS CASES LATER THIS MONTH. SURGEON SENT X-RAYS OF FILMS FROM AUGUST WHERE EVERYTHING WAS SECURE AND ON A 3 MONTH FOLLOW UP THE NEW X-RAYS SHOW THE SET CAPS HAD POPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24037575 ↗MalfunctionDec 17, 2025Migration; Migration
IT WAS REPORTED THAT THE ROD CAME OUT OF THE TULIP OF THE ILLIAC BOLT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23829519 ↗MalfunctionNov 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO CREO THREADED LOCKING CAP WERE REMOVED DUE TO PATIENT INFECTION POST OPERATIVELY.
Patient problems: Unspecified Infection
MAUDE report 20630313 ↗MalfunctionJul 26, 2024Migration; Migration
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REPLACE CREO LOCKING CAPS THAT MIGRATED POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 19843770 ↗MalfunctionJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE CREO LOCKING CAPS DUE TO INFECTION POST OPERATIVELY.
Patient problems: Unspecified Infection
MAUDE report 19584338 ↗MalfunctionJun 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING A REVISION SURGERY FOR A TRAUMA PATIENT, CREO HARDWARE WAS REMOVED DUE TO POST OPERATIVE BREAKAGE.
Patient problems: Insufficient Information
MAUDE report 19568877 ↗MalfunctionMay 14, 2024Migration; Migration
IT WAS REPORTED THAT A CREO THREADED LOCKING CAP WAS FOUND LOOSE POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 19309769 ↗MalfunctionApr 12, 2024Migration; Migration
IT WAS REPORTED THAT A REVISION WAS NEEDED TO REPLACE CREO LOCKING CAPS THAT BECAME LOOSE POST OPERATIVELY.
Patient problems: Spinal Column Injury
MAUDE report 19097397 ↗MalfunctionApr 1, 2024Migration; Migration
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REPLACE CREO THREADED LOCKING CAPS THAT WERE FOUND LOOSE POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Spinal Cord Injury
MAUDE report 19014539 ↗MalfunctionMar 5, 2024Material Separation; Material Separation
IT WAS REPORTED THAT FOUR CREO LOCKING CAPS HAD BACKED OUT OF THE SCREW HEADS POST-OPERATIVELY REQUIRING REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 18839368 ↗MalfunctionMar 5, 2024Material Separation; Material Separation
IT WAS REOORTED THAT A CREO LOCKINQ CAP BACKED OUT POST-OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 18839367 ↗MalfunctionMar 5, 2024Device Handling Problem; Device Handling Problem
DURING SURGERY THE LOCKING WAS BROKEN AND FRAGMENTS MAY BE LEFT IN THE PATIENT. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Insufficient Information
MAUDE report 18837935 ↗MalfunctionMar 5, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THERE WAS A REVISION SURGERY DUE TO CREO THREADED LOCKING CAPS THAT WERE FOUND LOOSE POST OPERATIVELY WITH SUBSEQUENT ROD DISPLACEMENT, CAUSING PATIENT PAIN. THIS EVENT OCCURRED IN IRELAND.
Patient problems: Spinal Column Injury
MAUDE report 18837893 ↗MalfunctionMar 5, 2024Device Handling Problem; Device Handling Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE A CREO THREADED LOCKING CAP DUE TO PATIENT PAIN, AND THE LOCKING CAP WAS FOUND NOT FULLY SEATED IN THE SCREW HEAD. THIS EVENT OCCURRED IN AUSTRIA.
Patient problems: Spinal Column Injury
MAUDE report 18837887 ↗MalfunctionMar 5, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A CREO THREADED LOCKING CAP HAS COME LOOSE POST OPERATIVELY WITH SUBSEQUENT ROD SLIPPAGE. THIS EVENT OCCURRED IN AUSTRIA.
Patient problems: Spinal Column Injury
MAUDE report 18837868 ↗MalfunctionMar 5, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THERE WAS A REVISION SURGERY DUE TO CREO THREADED LOCKING CAPS THAT WERE FOUND LOOSE POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Spinal Column Injury
MAUDE report 18837864 ↗MalfunctionMar 5, 2024Device Handling Problem; Device Handling Problem
IT WAS REPORTED THAT A CREO THREADED LOCKING CAP HAS COME LOOSE POST OPERATIVELY WITH SUBSEQUENT ROD SLIPPAGE. THIS EVENT OCCURRED IN AUSTRIA.
Patient problems: Insufficient Information
MAUDE report 18837806 ↗MalfunctionMar 5, 2024Break; Break
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED FOR A CREO THREADED LOCKING CAP THAT HAD COME LOOSE POST OPERATIVELY WITH SUBSEQUENT ROD SLIPPAGE. THIS EVENT OCCURRED IN AUSTRIA.
Patient problems: Insufficient Information
MAUDE report 18837804 ↗MalfunctionMar 5, 2024Break; Break
IT WAS REPORTED THAT A CREO THREADED LOCKING CAP HAS COME LOOSE POST OPERATIVELY WITH SUBSEQUENT ROD SLIPPAGE. THIS EVENT OCCURRED IN AUSTRIA.
Patient problems: Insufficient Information
MAUDE report 18837789 ↗MalfunctionMar 5, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THERE IS A CREO LOCKING CAP HAS BROKEN POST OPERATIVELY. THIS EVENT OCCURRED IN GERMANY.
Patient problems: Insufficient Information
MAUDE report 18834283 ↗MalfunctionMar 5, 2024Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THAT A CREO LOCKING CAP WAS FOUND LOOSE POST OPERATIVELY WITH SUBSEQUENT ROD MIGRATION. THIS EVENT OCCURRED IN THE UNITED KINGDOM.
Patient problems: Insufficient Information
MAUDE report 18834282 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
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- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 reports
- EXPEDIUM 179712645Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION33 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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