CREORecalls & reported problems across all models
Globus Medical, Inc. · 100 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 380
- Deaths reported
- 2
- Injuries reported
- 17
- Recalls
- 0
We found 100 models of CREO by Globus Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 380 adverse event reports in the FDA's MAUDE database, received between Sep 14, 2020 and Aug 11, 2026 — classified as 2 deaths, 17 injuries, 361 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (79 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CREO problems
Device problems
- Loose or Intermittent Connection79
- Migration52
- Fracture31
- Insufficient Device Problem Information29
- Device Slipped21
- Loosening of Implant Not Related to Bone-Ingrowth21
- Break20
- Detachment of Device or Device Component20
Patient problems
- Insufficient Information204
- Failure of Implant47
- No Clinical Signs, Symptoms or Conditions40
- Spinal Column Injury39
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available19
- Pain9
- Spinal Cord Injury5
- Unspecified Infection5
CREO models
100 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CREO 1134.0010ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- CREO 1119.0110APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY12 reports
- CREO 5119.1647Orthosis, spinal pedicle fixation, for degenerative disc disease10 reports
- CREO 6120.5000ORTHOPEDIC MANUAL SURGICAL INSTRUMENT10 reports
- CREO 1067.4645ORTHOSIS, SPINAL PEDICLE FIXATION7 reports
- CREO 1134.0100APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death7 reports
- CREO 5119.1642Pedicle screw spinal system, adolescent idiopathic scoliosis5 reports
- CREO 5119.1747ORTHOSIS, SPINAL PEDICLE FIXATION5 reports
- CREO 1067.0010APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY4 reports
- CREO 1067.4745Orthosis, spinal pedicle fixation, for degenerative disc disease4 reports
- CREO 1119.0000APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- CREO 1134.0110Pedicle screw spinal system, adolescent idiopathic scoliosis4 reports
- CREO 5119.6645Orthosis, spinal pedicle fixation, for degenerative disc disease4 reports
- CREO 1119.0011Orthosis, spinal pedicle fixation, for degenerative disc disease4 reports
- CREO 1192.0010Appliance, fixation, spinal intervertebral body4 reports
- CREO 5119.1742APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- CREO 7218.7880APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- CREO 7218.8880Thoracolumbosacral pedicle screw system2 reports
- CREO 1067.4345ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- CREO 1067.4545APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- CREO 1119.0046ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- CREO 1119.0150Orthosis, spondylolisthesis spinal fixation2 reports
- CREO 1119.7045APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- CREO 1119.7125Pedicle screw spinal system, adolescent idiopathic scoliosis2 reports
- CREO 5119.1547ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- CREO 5119.1732APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- CREO 5119.1982Pedicle screw spinal system, adolescent idiopathic scoliosis2 reports
- CREO 6120.2000ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- CREO 7067.7040Orthosis, spondylolisthesis spinal fixation2 reports
- CREO 7067.7060APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- CREO 7146.0110ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- CREO 1119.0050APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- CREO 1156.0010Thoracolumbosacral pedicle screw system2 reports
- CREO 5156.1800APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- CREO 7218.7195APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CREO 7218.8111APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CREO 7218.8190Thoracolumbosacral pedicle screw system1 report
- CREO 7218.8995Thoracolumbosacral pedicle screw system1 report
- CREO 1067.1330Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- CREO 1067.1545APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CREO 1067.1645ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- CREO 1067.1750ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- CREO 1067.4340ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- CREO 1067.4635APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CREO 1067.4640Orthosis, spondylolisthesis spinal fixation1 report
- CREO 1067.4740ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- CREO 1067.4755Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- CREO 1067.4810APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CREO 1067.4880Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- CREO 1119.0100APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CREO 1119.0600APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- CREO 1119.5125Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- CREO 1119.7050ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- CREO 1119.7055ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- CREO 1119.7070Orthosis, spondylolisthesis spinal fixation1 report
- CREO 1119.7085ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- CREO 1119.7090ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- CREO 1119.7150Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- CREO 1120.1150ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- CREO 1120.1500Orthosis, spondylolisthesis spinal fixation1 report
- CREO 1120.2200ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- CREO 1134.7050Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- CREO 1134.7055Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- CREO 1134.7095Orthosis, spondylolisthesis spinal fixation1 report
- CREO 1134.7140Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- CREO 5119.0542Orthosis, spondylolisthesis spinal fixation1 report
- CREO 5119.1537APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- CREO 5119.1645APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CREO 5119.1737Orthosis, spondylolisthesis spinal fixation1 report
- CREO 5119.1740Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- CREO 5119.1755APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- CREO 5119.1757Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- CREO 5119.1847APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- CREO 5119.1910Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- CREO 5119.2287Orthosis, spondylolisthesis spinal fixation1 report
- CREO 5119.2747APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CREO 5119.6440Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- CREO 5119.6640APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CREO 5119.6740Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- CREO 5146.1742Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- CREO 5146.1757Orthosis, spondylolisthesis spinal fixation1 report
- CREO 5146.1818APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- CREO 5146.1882APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- CREO 6120.2010ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 death1 report
- CREO 7067.7055APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- CREO 7067.7070ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- CREO 7067.8955Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- CREO 7119.6500ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- CREO 7134.7075Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- CREO 5119.1646SAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- CREO 5067.1327ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- CREO 5067.0631SORTHOSIS, SPINAL PEDICLE FIXATION1 report
- CREO 1175.1554Appliance, fixation, spinal intervertebral body1 report
- CREO 1175.4422Appliance, fixation, spinal intervertebral body1 report
- CREO 1175.6255Thoracolumbosacral pedicle screw system1 report
- CREO 1175.9913APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CREO 1192.0210Appliance, fixation, spinal intervertebral body1 report
- CREO 1192.1745Thoracolumbosacral pedicle screw system1 report
- CREO 5156.1745APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
Recent CREO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Fracture
It was reported that on (b)(6) 2026 it was found that the two screws implanted on both sides of the S2AI had fractured immediately below their heads. On (b)(6) 2026 a revision surgery was performed. The fractured screws could not be explanted and were consequently retained in the patient.
Patient problems: Insufficient Information
MAUDE report 50201313 ↗MalfunctionJul 27, 2026Fracture
Patient problems: Foreign Body In Patient
MAUDE report 50041808 ↗MalfunctionJul 16, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25846844 ↗MalfunctionJun 12, 2026Migration
IT WAS REPORTED RODS MOVED 2 MONTHS POST INSTRUMENTATION. THE RODS MIGRATED CRANIALLY UNTIL THEY WERE COMPLETELY DISPLACED FROM THE L5 SCREWS. THE SURGEON CHOSE TO PERFORM A REVISION SURGERY THE WEEK OF (B)(6) 2026 TO REMOVE THE HARDWARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25487078 ↗InjuryApr 21, 2026Migration
IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT UNDERWENT A SPINAL PROCEDURE USING CREO MIS. THEN ON (B)(6) 2026 THE REVISION SURGERY WAS PERFORMED DUE TO THE LOOSENING OF PEDICLE SCREWS AT L5. THE FIXATION AREA WAS EXTENDED FROM L2 TO ILIAC. THE SALE REP COMMENTED THAT THE PATIENT'S BONE QUALITY WAS POOR. THE LOCKING CAPS WERE OBTAINED, BUT THE LOOSE MIS SCREWS WERE NOT.
Patient problems: Unspecified Musculoskeletal problem
MAUDE report 24940788 ↗InjuryApr 17, 2026Migration
IT WAS REPORTED THAT REVISION SURGERY FOR SCOLIOSIS WAS PERFORMED DUE TO THE FACT THAT, ON X-RAY IMAGING, ONE OF THE LOCKING ELEMENTS (SET SCREWS) APPEARED TO BE LOOSENED. DURING THE PROCEDURE, IT WAS DISCOVERED THAT A SECOND LOCKING ELEMENT WAS ALSO LOOSE, ALTHOUGH THIS HAD NOT BEEN VISIBLE ON THE PREOPERATIVE X-RAY. THE SCREW WAS REPLACED WITH ONE OF A LARGER DIAMETER, AND THE SET SCREWS WERE REPLACED WITH NEW ONES. THE ISSUE CONCERNS THE USE OF COBALT-CHROMIUM RODS. AS OBSERVED IN THE ATTACHED IMAGE, WHEN A TITANIUM ROD IS USED, THE SET SCREW CAN BE TIGHTENED DEEPLY AND SITS FLUSH WITH THE SCREW HEAD (TULIP). HOWEVER, WHEN A COBALT-CHROMIUM ROD IS USED, THE SET SCREW CANNOT BE TIGHTENED FURTHER AND REMAINS SLIGHTLY PROTRUDING ABOVE THE LEVEL OF THE SCREW HEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911448 ↗MalfunctionApr 13, 2026Migration
IT WAS REPORTED THAT THE SURGEON REVISED A T8-PELVIS ON (B)(6) 2025 IN WHICH A SET CAP CAME OUT OF THE ILIAC BOLT THAT WAS CONNECTED TO AN ACCESSORY ROD. THE MAIN RODS OF THE CONSTRUCT FRACTURED AND A REVISION WAS REQUIRED. THE SURGEON ADDED 3 TLIFS DURING THE REVISION AND REPLACED THE MAIN RODS AND ACCESSORY RODS. HE ALSO UPSIZED 4X SCREWS OF THE ORIGINAL CONSTRUCT DUE TO HALOING OF THE BONE AROUND THE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865829 ↗MalfunctionApr 7, 2026Fracture
IT WAS REPORTED THAT ON (B)(6) 2025, SURGERY WAS PERFORMED TO EXTEND THE FIXATION AREA FOR THE PATIENT WITH L5/S POSTERIORLY FIXED BY CREO DUE TO INFECTION. THE SURGEON TRIED TO REMOVE THE LOCKING CAP ON THE RIGHT S SUING A DRIVER, BUT IT WOULD NOT COME OFF. AS A RESULT, FOUR DRIVERS WERE USED, BUT ALL OF WHICH BROKE OFF. ONE OF THESE DRIVERS LEFT A BROKEN PIECE INSIDE THE LOCKING CAP. THE BROKEN PIECE COULD NOT BE REMOVED AND REMAINS IN THE LOCKING CAP. THE SURGEON INSERTED SCREWS INTO THE SAI AND CONNECTED THE RODS USING A COMPETITOR'S CONNECTOR.
Patient problems: Foreign Body In Patient
MAUDE report 24802193 ↗MalfunctionMar 24, 2026Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF THE L4/S1 ROD DUE TO ADJACENT SEGMENT DISEASE. INTRAOPERATIVELY, THE SURGEON NOTICED THAT THE ROD WAS BROKEN AT THE LEFT L4 LEVEL. THE SURGEON FIXED L1/S1 USING CREO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24673843 ↗MalfunctionMar 19, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT THE SURGEON DID A L3-S1 CREO ONE REVISION AS S1 SCREWS WERE LOOSE. THE PLAN WAS TO REPLACE SCREWS AT S1 AND ADD S2A1 SCREWS THEN REMOVE SET SCREWS AND RODS FROM OLD CONSTRUCT AND PLACE A LONGER ROD CONNECTING ALL SCREWS. THE SET SCREWS ON 5 SCREWS AND ONE SIDE BY SIDE ROD CONNECTOR WERE COLD WELDED AND COULDN'T BE REMOVED. A CUSTOM HEAD SPLAYER WAS USED AND SET SCREWS WERE THEN EASILY REMOVED. THE 5 SCREWS THAT WERE REMOVED WERE REPLACED WITH LARGER DIAMETER SCREWS. THE S1 CREO ONE SCREWS WERE REPLACED WITH SI BONE GRANITE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24643629 ↗MalfunctionFeb 20, 2026Migration
IT WAS REPORTED THAT THERE WAS A REVISION FOR LOOSE SET SCREW AND TULIPS AT L5 RIGHT. RIGHT SIDE OF THE CONSTRUCT WAS REPLACED WITH 2X FRESH 30MM TULIPS AND 2X SET SCREWS. THE POST OP CT SCAN CONFIRMED CORRECT AND LOCKED OFF PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402019 ↗MalfunctionFeb 18, 2026Fracture
IT WAS REPORTED THAT THERE WAS A REVISION SURGERY FOR BROKEN RODS. DURING THE REVISION THE TIP OF DRIVER BROKE WHILE REMOVING SET SCREW/LOCKING CAP. NO PIECES WERE LEFT IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377544 ↗MalfunctionFeb 13, 2026Fracture
IT WAS REPORTED THAT DURING A REVISION TO ADDRESS SUBSEQUENT HERNIATION ON (B)(6) 2024 PREVIOUSLY IMPLANTED CREO TITANIUM RODS WERE FOUND TO BE CRACKED. THESE DEVICES WERE EXPLANTED.
Patient problems: Insufficient Information
MAUDE report 24332158 ↗MalfunctionFeb 6, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT THE CREO THREADED SET SCREWS NEEDED TO BE REMOVED DUE TO INFECTION, AND THE SET SCREWS WERE STUCK. WE USED THE CUSTOM INSTRUMENT HEAD PLAYER TO SPLAY THE HEADS AND REMOVE THE SET SCREWS. ALL CREO ONE SCREWS WERE REMOVED, AND SEVERAL, IF NOT ALL, OF THE HEADS WERE LOCKED AND HAD NO POLYAXIAL MOVEMENT. THE ORIGINAL SURGERY WAS ON (B)(6) 2025. THE SCREWS AND SET SCREWS WERE SENT TO THE LAB FOR CULTURING AND WILL BE RETURNED WHEN THAT IS FINISHED.
Patient problems: Unspecified Infection
MAUDE report 24282703 ↗MalfunctionFeb 5, 2026Fracture
THE PATIENT HAD AN L4-S1 INTERBODY FUSION WITH THE CREO 4.75 SCREW SYSTEM ON (B)(6) 2023. THE PATIENT RETURNED TO THE SURGEON IN LATE 2025 FOR PAIN. SURGEON DETERMINED THE PATIENT HAD ADJACENT LEVEL DISEASE AT L3-4 AND POSSIBLY AN IMMATURE FUSION FROM THE PREVIOUS SURGERY AT L4-S1. THE PATIENT WAS SCHEDULED FOR AN L3-4 POSTERIOR INTERBODY FUSION, WHICH WAS DONE ON (B)(6) 2026. DURING THE SURGERY ON (B)(6) IT WAS DETERMINED THAT ONE OF THE PREVIOUSLY PLACED 4.75 COBALT CHROME RODS WAS BROKEN, AND THE PATIENT HAD NOT FULLY HEALED/FUSED FROM THE ORIGINAL SURGERY.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 24270694 ↗
Other Globus Medical, Inc. products
All Globus Medical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
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