CREO 1134.0010Recalls & reported problems
Globus Medical, Inc. · CREO MIS Locking Cap · Class 2
Quick summary
This Globus CREO MIS locking cap is a small cap that locks rods to screws in spinal fusion surgery. Many of the 112 reports describe locking caps coming loose, popping out, or backing out after surgery, and some say revision surgery was needed. The reports include no injuries and no deaths. 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
- 112
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 00889095071139), received between Sep 14, 2020 and Dec 23, 2025 — classified as 112 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (38 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loose or Intermittent Connection38
- Migration25
- Loosening of Implant Not Related to Bone-Ingrowth11
- Device Slipped8
- Insufficient Device Problem Information8
- Appropriate Device Problem Term/Code Not Available6
- Detachment of Device or Device Component4
- Device Dislodged or Dislocated4
Patient problems
- Insufficient Information69
- Failure of Implant14
- No Clinical Signs, Symptoms or Conditions11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Spinal Column Injury6
- Pain2
- Fall1
- Implant Pain1
Recent adverse event reports
The 25 most recent of 112 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2025Migration; Migration
IT WAS REPORTED THAT THE SET CAP POPPED OUT OF CREO MIS SCREW POST OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879740 ↗MalfunctionDec 23, 2025Migration; Migration
IT WAS REPORTED THAT THE SET CAP POPPED OUT OF CREO MIS SCREW POST OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879738 ↗MalfunctionOct 27, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT CAME IN FOR A POST OPERATION VISIT AND THE SURGEON NOTICED THE CREO LOCKING CAP HAD RELEASED FROM THE TULIP HEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23392127 ↗MalfunctionOct 24, 2025Migration; Migration
IT WAS REPORTED THAT AFTER THE FIRST SURGERY IN THE BEGINNING OF 2025 THE PATIENT NOTICED SOME STRANGE NOISE AFTER A TIME. (B)(6) 2025 WAS THE REVISION SURGERY AND AT ONE SCREW (1 OUT OF 4) THE LOCKING CAP WAS LOOSENING. THE SURGEON TOOK THE TL HANDLE AND FIXED THE LOCKING CAP.
Patient problems: Insufficient Information
MAUDE report 23379939 ↗MalfunctionSep 2, 2025Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED DUE TO CREO MIS LOCKING CAPS BACKING OUT. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Spinal Column Injury
MAUDE report 22939535 ↗MalfunctionSep 2, 2025Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT A REVISION SURGERY OCCURRED DUE TO A CREO MIS LOCKING CAP AND SCREW BACKING OUT. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Spinal Column Injury
MAUDE report 22939423 ↗MalfunctionFeb 27, 2025Migration; Migration
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE LOOSE CREO MIS LOCKING CAPS FOUND POST OPERATIVELY. THIS EVENT OCCURRED IN AUSTRALIA.
Patient problems: Spinal Column Injury
MAUDE report 21482560 ↗MalfunctionDec 30, 2024Migration; Migration
IT WAS REPORTED THAT A CREO MIS LOCKING CAP WAS FOUND LOOSE POST OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21039567 ↗MalfunctionSep 17, 2024Migration; Migration
IT WAS REPORTED THAT A REVISION WAS NEEDED TO REPLACE CREO MIS LOCKING CAP THAT WAS FOUND MIGRATED POST OPERATIVELY WITH SUBSEQUENT LOOSENED SET SCREWS.
Patient problems: Insufficient Information
MAUDE report 20239561 ↗MalfunctionJul 26, 2024Migration; Migration
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REPLACE CREO MIS LOCKING CAPS THAT MIGRATED POST OPERATIVELY WITH SUBSEQUENT ROD SLIPPAGE.
Patient problems: Insufficient Information
MAUDE report 19843732 ↗MalfunctionJul 8, 2024Human-Device Interface Problem; Migration; Human-Device Interface Problem; Migration
IT WAS REPORTED THAT A CREO LOCKING CAP WAS FOUND LOOSE POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 19693155 ↗MalfunctionMar 5, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT REVISION SURGERY WAS NEEDED TO REPLACE CREO MIS LOCKING CAPS THAT WERE FOUND LOOSENED POST OPERATIVELY WITH SUBSEQUENT SPACER MIGRATION. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Spinal Column Injury
MAUDE report 18837933 ↗MalfunctionMar 5, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A REVISION WAS NEEDED TO REPLACE A CREO MIS LOCKING HEAD THAT WAS FOUND LOOSE POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Spinal Column Injury
MAUDE report 18837913 ↗MalfunctionMar 5, 2024Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO LOCKING CAPS FOUND LOOSE POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Insufficient Information
MAUDE report 18834298 ↗MalfunctionMar 5, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT REVISION SURGERY WAS NEEDED TO REPLACE CREO MIS LOCKING CAPS THAT WERE FOUND LOOSENED 1 WEEK POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18834281 ↗MalfunctionMar 5, 2024Migration; Migration
IT WAS REPORTED THAT A LOCKING CAP HAS LOOSENED POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18834229 ↗MalfunctionMar 4, 2024Unintended Movement; Unintended Movement
INITIAL SURGERY WAS PERFORMED WITH SCREWS PLACED FROM L2 TO S1. NO ANTERIOR COLUMN SUPPORT WAS USED. TWO DAYS POST-OPERATIVELY THE PATIENT PRESENTED WITH AN AUDIBLE NOISE OF WHAT SOUNDED LIKE METAL MOVING ON METAL. NOTHING WAS VISIBLE ON X-RAY; HOWEVER, DURING REVISION SURGERY THE LOCKING CAPS WERE FOUND LOOSE AT L2 AND L3 ON THE PATIENT'S LEFT SIDE.
Patient problems: Failure of Implant
MAUDE report 18831845 ↗MalfunctionMar 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT FIVE CREO MIS LOCKING CAPS WERE FOUND LOOSENED APPROXIMATELY SIX MONTHS POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18827081 ↗MalfunctionMar 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT ONE CREO MIS LOCKING CAP HAD BEEN LEFT IN THE PATIENT DURING THE INITIAL SURGERY. ADDITIONALLY, IT WAS FOUND THAT THE RIGHT LAND L5 LOCKING CAPS BACKED OUT OF THE SCREW HEAD POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18827054 ↗MalfunctionMar 4, 2024Migration; Migration
IT WAS REPORTED THAT FOUR CREO MIS LOCKINQ CAPS BACKED OUT OF THE SCREW HEAD POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18825411 ↗MalfunctionMar 2, 2024Device Slipped; Device Slipped
IT WAS REPORTED FROM A GLOBUS MEDICAL JAPAN REPRESENTATIVE, THAT SIX LOCKING CAPS WERE FOUND TO BE LOOSE APPROXIMATELY TWO MONTHS POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18823403 ↗MalfunctionMar 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A CREO MIS LOCKING CAP LOOSENED APPROXIMATELY ONE YEAR AND TWO MONTHS POST-OPERATIVE.
Patient problems: Insufficient Information
MAUDE report 18823397 ↗MalfunctionMar 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT SIX LOCKING CAPS HAD LOOSENED APPROXIMATELY ONE YEAR POST-OPERATIVE REQUIRING REVISION SURGERY TO REPLACE.
Patient problems: Insufficient Information
MAUDE report 18823396 ↗MalfunctionMar 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED BY GLOBUS MEDICAL JAPAN, THAT SIX LOCKING CAPS LOOSENED POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18823392 ↗MalfunctionMar 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS FOUND DURING REVISION SURGERY THAT FOUR LOCKING CAPS HAD LOOSENED ONE WEEK POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18823383 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.