CREO 1119.0011Recalls & reported problems
Globus Medical, Inc. · CREO Threaded Locking Cap, BN · Class 2
All models of CREO (100)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889095306491), received between Mar 16, 2021 and Mar 19, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
- Loose or Intermittent Connection2
- Device Slipped1
- Expulsion1
- Migration1
Patient problems
- Insufficient Information2
- Failure of Implant1
- Spinal Cord Injury1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT A REVISION WAS NEEDED TO REPLACE CREO LOCKING CAPS THAT WERE FOUND LOOSE POST OPERATIVELY. THIS EVENT OCCURRED IN AUSTRIA.
Patient problems: Spinal Cord Injury
MAUDE report 18935122 ↗MalfunctionMar 4, 2024Migration; Migration
IT WAS REPORTED THAT ONE MONTH POST-OPERATIVELY, A CREO THREADED LOCKING CAP AT L5 HAD BACKED OUT REQUIRING REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 18832552 ↗MalfunctionMar 1, 2024Expulsion; Expulsion
IT WAS REPORTED THAT A REVISION SURGERY WAS DONE TO REPLACE 4 LOCKING CAPS WHICH HAD COME LOOSE POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18817739 ↗MalfunctionMar 16, 2021Loose or Intermittent Connection; Device Slipped
IT WAS REPORTED THAT FOLLOWING A REVISION SURGERY TO REPLACE LOOSE LOCKING CAPS, THE 4 REPLACEMENT CAPS CAME OFF POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 11499053 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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