CD HORIZON® Spinal System RBT033102Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000011314), received between May 17, 2024 and Mar 2, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT THE SCREWDRIVER BROKE DURING PROCEDURE. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE INVOLVED WAS L3/5 FUSION. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. SCREWDRIVER DID NOT COME INTO CONTACT WITH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21500926 ↗
• MalfunctionFeb 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE DRIVER HAS BROKEN. 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 21442392 ↗
• MalfunctionFeb 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVERS USED FOR SPINAL THERAPY. IT WAS RE PORTED THAT RATCHETING HANDLE BROKE AND THE PROBE EXPERIENCED AN ISSUE WHERE THE NAV LOCK FRAME WOULD NOT SLIDE IN AND SLEEVE DRIVERS WAS BROKEN. THE TIP OF THE NAV AND MAS DRIVERS BROKE. 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 21320313 ↗
• MalfunctionJan 31, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING INSTRUMENTS USED IN UNKNOWN SP INAL THERAPY. IT WAS REPORTED THAT DRIVERS WERE BROKEN. 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 21280871 ↗
• MalfunctionNov 26, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT USED IN SACROILIAC AND THORACOLUMBAR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS SEEMED TO BE STICKING, LATER THE TIPS WERE BROKEN. THERE WAS A DELAY LESS THAN ONE HOUR AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THIS EVENT ADDED 30MINS DELAY. LEVELS IMPLANTED: L2-S2AI FIXATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20780400 ↗
• MalfunctionAug 20, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER SHEARED OFF WHILE PLACING SCREW. 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 20007856 ↗
• MalfunctionMay 17, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE SCREWDRIVER WAS DEFECTIVE. THE PATIENT INVOLVED IN THIS EVENT IS UNKNOWN AND NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE TIP ON THE TORX HAS BEEN BROKEN. EVENT OCCURRED DURING INTRA OP WHILE SCREW MANIPULATING AND PATIENT WAS NOT HARMED BY INCIDENT AND NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340728 ↗