CREO 5067.0631SRecalls & reported problems
Globus Medical, Inc. · CREO 4.75, 6.5 x 30mm HA Coated Monoaxial Screw · Class 2
All models of CREO (100)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889095339635), received between Mar 4, 2024 and Mar 4, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
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
- Improper or Incorrect Procedure or Method1
Patient problems
- Spinal Cord Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 4, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE PATIENT WAS TREATED USING ANTERIOR TETHERING FOR ADOLESCENT IDIOPATHIC SCOLIOSIS IN TURKEY TWO MONTHS PRIOR TO REVISION. THE PATIENT IS A 15 YEAR OLD UK CITIZEN, TAKEN ABROAD FOR SURGERY BY PARENTS. PRESENTED TO OUR UNIT WITH TWO LITRE HAEMOTHORAX. AT REVIEW TWO SCREWS ADJACENT TO DESCENDING AORTA, TWO SCREWS ERODED THROUGH THE DIAPHRAGM AND TWO SCREWS COMPRESSING RENAL ARTERY AND ADRENAL GLAND.
Patient problems: Spinal Cord Injury
MAUDE report 18831759 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 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
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.
How reports and recalls are matched · Editorial policy · Report an error on this page