CREO 1192.0010Recalls & reported problems
Globus Medical, Inc. · CREO Fenestrated, Locking Cap, Threaded · Class 2
- 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 00889095541656), received between Jun 8, 2021 and Oct 3, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth3
- Migration or Expulsion of Device2
- Appropriate Device Problem Term/Code Not Available1
- Loose or Intermittent Connection1
Patient problems
- Failure of Implant3
- Pain2
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2022Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THERE WAS A REVISION SURGERY DUE TO A CREO FENESTRATED LOCKING CAP THAT WAS LOOSE WITH SUBSEQUENT ROD MIGRATION 4 MONTHS POST OPERATIVELY AND CAUSING PATIENT PAIN.
Patient problems: Failure of Implant; Pain
MAUDE report 15527772 ↗MalfunctionSep 13, 2022Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THERE WAS A REVISION SURGERY DUE TO A CREO FENESTRATED LOCKING CAPS THAT WAS LOOSE 8 MONTHS POST OPERATIVELY CAUSING PATIENT PAIN AND SUBSEQUENT ROD MIGRATION.
Patient problems: Failure of Implant
MAUDE report 15413422 ↗MalfunctionSep 9, 2022Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THERE WAS A REVISION SURGERY DUE TO A CREO FENESTRATED LOCKING CAPS THAT WAS LOOSE 1 YEAR POST OPERATIVELY AND CAUSING PATIENT PAIN.
Patient problems: Failure of Implant; Pain
MAUDE report 15392006 ↗MalfunctionJun 8, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED BY A REPRESENTATIVE FROM AUSTRIA, THAT A REVISION SURGERY AS DONE DUE TO CREO MIS LOCKING CAPS LOOSENING POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 11962266 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.