CD HORIZON® Spinal System RBT033302Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000011284), received between Jun 4, 2024 and Mar 3, 2025 — classified as 2 malfunctions.

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

• MalfunctionMar 3, 2025Break; Device Handling Problem; Break; Device Handling Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SURGEON SHEARED THE DRIVER WHEN ATTEMPTING TO SCREW IN A SCREW IN THE PATIENT. THE SURGEON USED POWER EASE ON ALL SCREWS. THE SCREW HOLES WERE DRILLED AND TAPPED BEFORE INTRODUCING THE IMPLANTING SCREWS. HOWEVER, DUE TO THE PATIENT'S INCREASED BONE DENSITY, THE POWER EASE HAD A HARD TIME SCREWING IN ALL SIX SCREWS IN THE CASE. THE SCOPE WAS FROM L4 TO S1. HOWEVER, ON S1 ON THE RIGHT, THE SURGEON STOPPED THE POWER EASE IN THE MIDDLE OF SCREWING IN THE SCREW. DAVID SAID THAT SINCE THE SURGEON STOPPED THE POWER EASE BEFORE THE SCREW WAS FULLY INSERTED, THE POWER EASE WAS UNABLE TO CONTINUE SCREWING IN THE SCREW. THE SURGEON AT THAT POINT INTRODUCED THE DRIVER WITH A HANDLE. HOWEVER, THE SURGEON DID NOT ATTACH THE DRIVER TO THE SCREW BY SCREWING THE DRIVER TO THE SCREW USING THE THREADS. THE SURGEON ONLY ATTACHED THE HEAD OF THE DRIVER TO THE HEAD OF THE SCREW WHICH SHEARED THE HEAD OF THE DRIVER IN THE HEAD OF THE SCREW. THEY WERE NOT ABLE TO REMOVE THE SHEARED DRIVER HEAD FROM THE HEAD OF THE SCREW, SO THE SCREW HAD TO BE REMOVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511559 ↗
• MalfunctionJun 4, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE DEVICE HAS BROKEN. THE TIP WAS BROKEN OFF. PRODUCT WILL BE RETURNED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19461978 ↗