CarboClear X Pedicle Screw System Pedicle Screw - CannulatedRecalls & reported problems
Carbofix Orthopedics Ltd · Cannulated pedicle screw · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290110209896), received between May 27, 2022 and May 27, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2022Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component
CARBOCLEAR X PEDICLE SCREW SYSTEM WAS USED IN A REVISION SURGERY FOR THE TREATMENT OF DEFORMITY SCOLIOSIS FOR A METAL ALLERGY PATIENT (THE ORIGINAL SURGERY WAS PERFORMED WITH METAL PEDICLE SCREW SYSTEM OF ANOTHER COMPANY; CARBOCLEAR X SYSTEM OR ANY OTHER IMPLANT OF CARBOFIX WERE NOT USED IN THE FIRST OPERATION). A LONG CONSTRUCT WAS INVOLVED (T4 - ALA). TITANIUM SCREWS WERE REPLACED WITH CARBOCLEAR X SCREWS. DUE TO THE LENGTH OF THE RODS REQUIRED, THE SURGEON USED PRE-BENT TITANIUM RODS OF ANOTHER COMPANY. DURING INSERTION OF A CARBOCLEAR X SCREW INTO A LOW LUMBAR VERTEBRA, THE SCREW' TULIP WAS DISASSEMBLED FROM THE SCREW. NO TAPPING WAS CONDUCTED PRIOR TO SCREW INSERTION INTO THE VERTEBRA. THE DISASSEMBLED SCREW WAS REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14521419 ↗
Other Thoracolumbosacral Pedicle Screw System devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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