CD HORIZON® Spinal System RBT033101Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000011307), received between Feb 12, 2025 and Feb 16, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS BROKEN DURING NORMAL USAGE. THERE IS NO PATIENT INVOLVEMENT REPORTED AND NO FURTHER COMPLICATIONS OR SYMPTOMS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24342168 ↗
• MalfunctionJun 24, 2025Break; Material Deformation; Break; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER SCREW WAS STRIPPED AND THE TIP BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE TYPE OF PROCEDURE INVOLVED DURING THE EVENT WAS LUMBAR FUSION WITH ROBOT L2-P.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319438 ↗
• MalfunctionFeb 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW USING A DRIVER IN A SCREW INSERTION FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT THE DRIVER TIP SNAPPED DURING TIGHT FITTING. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457027 ↗
• MalfunctionFeb 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCTS. IT WAS REPORTED THAT, THE TIPS OF THE DRIVERS WERE BROKEN. THERE WAS NO PATIENT INVOLVED DURING THIS EVENT. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444508 ↗
• MalfunctionFeb 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCTS. IT WAS REPORTED THAT, THE TIPS OF THE DRIVERS WERE BROKEN. THERE WAS NO PATIENT INVOLVED DURING THIS EVENT. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444442 ↗
• MalfunctionFeb 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T4-PELVIS PSF FOR AN INDICATION OF SCOLIOSIS. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN AND THE TAB ON SHAFT IS BROKEN, NO LONGER RETAINS SET SCREWS AND THE FLEX ARM WILL NOT TIGHTEN. THE DRIVERS CAME IN CONTACT WITH THE PATIENT BUT THE FLEX ARM WAS NOT BEING USED ON THE PATIENT WHILE THE MALFUNCTION WAS NOTICED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442401 ↗
• MalfunctionFeb 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T4-PELIVIS PSF FOR AN INDICATION OF SCOLIOSIS. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN AND THE TAB ON SHAFT IS BROKEN, NO LONGER RETAINS SET SCREWS AND THE FLEX ARM WILL NOT TIGHTEN. THE DRIVERS CAME IN CONTACT WITH THE PATIENT BUT THE FLEX ARM WAS NOT BEING USED ON THE PATIENT WHILE THE MALFUNCTION WAS NOTICED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442395 ↗
• MalfunctionFeb 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPINAL DEVICE USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENT HAD REALLY HARD BONE MAKING THE ADVANCEMENT VERY DIFFICULT. THE SCREW WAS REMOVED AND THE HOLE RETAPED WITH A 6.5MM TAP. THE SCREW WAS THEN REINSERTED WITH THE POWER EASE WITH TORQUE MULTIPLIER. THE SCREW WAS INSERTED UNTIL IT WOULD NOT ADVANCE ANY FURTHER. THE SCREW WAS BACKED OUT A FEW TURNS AND RE-ADVANCED UNTIL IT STOPPED AGAIN. WHILE TRYING TO ADVANCE IT FURTHER THE TIP OF THE DRIVER BROKE OFF INSIDE OF THE HEAD OF THE SCREW. THE TIP IS STILL IN THE SCREW. PATIENT MEDICAL HISTORY WAS PREVIOUS SPINE SURGERY. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THIS EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362213 ↗