CarboClear Pedicle Screw System Rod - Type 4Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290109336367), received between Apr 29, 2021 and Feb 25, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2025Break; Break

  INITIALLY, A SURGERY WITH THE CARBOCLEAR X PEDICLE SCREW SYSTEM TO TREAT AN ONCOLOGICAL 61-YEAR-OLD PATIENT WAS PERFORMED ON (B)(6) 2022, IN CANADA. THE CRBOCLEAR X SYSTEM WAS UTILIZED IN ORDER TO STABILIZE T5 - T10 VERTEBRAE WHILE T8 WAS REMOVED AND A VBR DEVICE WAS USED. ON (B)(6) 2025, CARBOFIX WAS INFORMED BY ITS CANADIAN DISTRIBUTOR THAT WHILE THE PATIENT WAS "WORKING ON HIS CAR" HE NOTICED PAIN. IMAGING WAS CONDUCTED AND REVEALED A BROKEN ROD. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, WHERE THE BROKEN ROD (CARBOCLEAR SHAPED ROD TYPE 4: DIAMETER - 6.0MM, LENGTH - 285MM) WAS REPLACED WHILE EXPANDING THE CONSTRUCT WITH NEW RODS FROM T4 TO T11. TWO (2) RODS AND 4 SCREWS (CARBOCLEAR X SYSTEM COMPONENTS) WERE USED.

  Patient problems: Back pain

  MAUDE report 21456097 ↗
• InjuryApr 29, 2021Fracture; Fracture

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

  Patient problems: Paralysis; Spinal Cord Injury

  MAUDE report 11744190 ↗