CREO 1134.0100Recalls & reported problems
Globus Medical, Inc. · CREO MIS Modular Polyaxial Tulip, 30mm reduction · Class 2
All models of CREO (100)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889095071146), received between Mar 1, 2024 and Aug 1, 2025 — classified as 1 death, 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
- Migration or Expulsion of Device1
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions1
- Spinal Column Injury1
- Spinal Cord Injury1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryAug 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT SCREW USING, PATIENT HAD SURGERY 2 MONTHS AGO AND RETURNED WITH LEFT SIDE HARDWARE LOOSE. L3 TULIP WAS NOT ATTRACTED TO SCREW SHANK.
Patient problems: Spinal Column Injury
MAUDE report 22689822 ↗MalfunctionJul 12, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT A CREO MIS SCREW HEAD HAS DISASSOCIATED FROM THE SHANK POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 19734660 ↗MalfunctionMar 5, 2024Break; Break
IT WAS REPORTED A REVISION WAS NEEDED FOR A CREO MIS MODULAR POLYAXIAL TULIP THAT HAD BROKEN POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18837558 ↗MalfunctionMar 5, 2024Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT A CREO MIS SCREW HEAD DISASSOCIATED FROM THE SHANK POST OPERATIVELY ON AN L3-5 FUSION, CAUSING SUBSEQUENT ROD MIGRATION ON L4 AND L5.
Patient problems: Insufficient Information
MAUDE report 18834301 ↗DeathMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DESCRIPTION OF THE EVENT STATES THAT HALOING WAS OBSERVED AROUND THE TRANSITION SCREW. HALOING IS AN INDICATION OF SCREW MOVEMENT POST-OPERATIVELY, SUGGESTING THAT FIXATION WAS COMPROMISED AT THIS LEVEL. IT'S POSSIBLE THAT THIS COULD HAVE BEEN CAUSED BY EXCESSIVE STRESS, IMPROPER SCREW SIZING, POOR BONE PURCHASE, OR PSEUDOARTHROSIS AT THAT LEVEL. THE SCREW WAS NOT RETURNED FOR EVALUATION AND THE RADIOGRAPHIC IMAGES WERE NOT AVAILABLE. THE EXACT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED.
Patient problems: Spinal Cord Injury
MAUDE report 18826911 ↗MalfunctionMar 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A CREO MIS MODULAR POLYAXIAL TULIP POPPED OFF THE SHANK DURING SURGERY AND WAS LEFT IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 18822026 ↗MalfunctionMar 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE SCREW HEAD POPPED OFF FROM THE SCREW SHANK. THIS WASN'T NOTICED UNTIL IT WAS SEEN ON THE POST-OPERATIVE X-RAY WHICH WAS TAKEN FOR REASONS UNRELATED TO THE SCREW SEPARATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18815497 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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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