CREO 1119.0110Recalls & reported problems
Globus Medical, Inc. · Polyaxial Tulip, Threaded, CREO AMP · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00889095059656), received between Jul 28, 2021 and Mar 5, 2024 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Device Slipped1
- Human-Device Interface Problem1
- Material Fragmentation1
- Material Integrity Problem1
- Material Separation1
- Mechanical Problem1
- Migration or Expulsion of Device1
Patient problems
- Insufficient Information8
- Spinal Column Injury2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Failure of Implant1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A CREO AMP THREADED POLYAXIAL TULIP HEAD HAS DISSOCIATED FROM THE SHANK POST OPERATIVELY.
Patient problems: Spinal Column Injury
MAUDE report 18837582 ↗MalfunctionMar 5, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THERE WAS A REVISION DUE TO CREO AMP THREADED POLYAXIAL SCREW HEADS BACKING OUT OF A CONSTRUCT POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18834300 ↗MalfunctionMar 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT ONE OF THE POLYAXIAL SCREW HEADS DETACHED FROM THE SCREW SHANK POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18830745 ↗MalfunctionMar 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
THE PATIENT REPORTED TO THE SURGEON THAT THEY HAD FALLEN (DATE NOT PROVIDED}. X-RAYS SHOW THAT 3 SCREWS PULLED OUT OF THE BONE AND 1 SCREW HEAD PULLED OFF OF THE SCREW SHANK OF A FOURTH SCREW. REVISION SURGERY WAS PERFORMED, THE HARDWARE WAS REPLACED AND THE CONSTRUCT WAS EXTENDED.
Patient problems: Failure of Implant
MAUDE report 18825601 ↗MalfunctionMar 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A CREO AMP THREADED SCREW HEAD DISASSOCIATED FROM THE SCREW SHANK POST-OPERATIVELY. THIS RESULTED IN THE LOSS OF CORRECTION OF SPONDYLOLISTHESIS. THE PATIENT WAS REVISED USING CREO THREADED FENESTRATED SCREWS AND FORTRESS CEMENT.
Patient problems: Insufficient Information
MAUDE report 18820154 ↗MalfunctionFeb 29, 2024Material Fragmentation; Material Fragmentation
ORIGINAL CASE WAS ON (B)(6) 2017. POST-OPERATIVE SIX WEEK FILMS SHOW THE SCREW HAD COMPLETELY PULLED OUT OF THE SCREW HEAD. THE SCREW HEAD WAS BROKEN AND THE ROD WAS NOT WITH THE SCREW HEADS. SURGEON REVISED AND ADDED ADDITIONAL SCREWS. THE SCREW HEAD WAS BROKEN IN TWO PIECES WHEN THE REVISION TOOK PLACE. PATIENT STATES THERE WAS NO FALL PRIOR TO THE BREAKAGE.
Patient problems: Insufficient Information
MAUDE report 18812623 ↗MalfunctionFeb 29, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT A REVISION WAS PERFORMED TO REPLACE A CREO SCREW HEAD THAT WAS FOUND SEPARATING FROM THE SHANK POST OPERATIVELY. PIECES OF METAL WERE ALSO REMOVED FROM THE PATIENT. THIS EVENT OCCURRED IN GERMANY.
Patient problems: Insufficient Information
MAUDE report 18810898 ↗MalfunctionFeb 19, 2024Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT DURING A REVISION SURGERY A CREO AMP THREADED POLYAXIAL SCREW HEAD WAS FOUND SEPARATED FROM THE IMPLANT POST OPERATIVELY.
Patient problems: Spinal Column Injury
MAUDE report 18734419 ↗MalfunctionOct 5, 2022Migration or Expulsion of Device
IT WAS REPORTED THAT A CREO AMP THREADED POLYAXIAL TULIP HAS MIGRATED FROM THE SCREW SHANK POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 15542141 ↗MalfunctionAug 22, 2022Material Separation
IT WAS REPORTED A CREO AMP THREADED POLYAXIAL TULIP HEAD HAS SEPARATED FROM THE S2 SCREW SHANK POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 15264458 ↗MalfunctionMay 20, 2022Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THERE WAS A REVISION SURGERY DUE TO (2) SCREW HEADS FAILING POST OPERATIVELY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14455306 ↗MalfunctionJul 28, 2021Device Slipped
IT WAS REPORTED THAT A REVISION SURGERY WAS DONE FOR A CREO SCREW HEAD THAT POPPED OFF THE SCREW ONE WEEK POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 12242233 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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