CD Horizon® Spinal System 1604300500Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169026285), received between Mar 9, 2022 and Sep 5, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR FRACTURE OF THE LEFT ROD. IT WAS REPORTED THAT THE LEFT ROD WAS BROKEN AT L5/S, SO IT WAS REPLACED. THE RODS ON BOTH SIDES WERE REPLACED, AND THE ILIAC SCREW WAS ADDED FOR REINFORCEMENT. THE LEVEL AT WHICH IMPLANT WAS PERFORMED IS T8-IL. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977880 ↗
• MalfunctionMar 21, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING EXTENDED OPERATION WITH A POSTERIOR L1-S2AI FIXATED 2 WEEKS AGO FOR KYPHOSIS. IT WAS REPORTED THAT WHILE USING THE INSITU-BENDER TO REMOVE THE ROD FROM THE DISTAL END, THE ROD WAS BROKEN NEAR TH12/L1 ON THE LEFT SIDE. IT WAS REPLACED WITH A NEW ROD AND THE SURGERY WAS COMPLETED. 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 21662013 ↗
• InjuryApr 24, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST ROD FRACTURE AFTER L5/S2 PLF PROCEDURE TO EXPLANT THE ROD. IT WAS REPORTED THAT SET SCREW FINAL TIGHTENING IS NOT POSSIBLE; THE SET SCREW THREAD IS DAMAGED. IT IS UNKNOWN IF THE ISSUE IS WITH CONNECTOR SIDE OR A PROBLEM WITH THE SET SCREW. THERE WAS A DELAY OF LESS THAN 60 MINS. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19170538 ↗
• InjuryApr 20, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T10-ILIAC POSTERIOR FUSION. IT WAS REPORTED THAT THE ROD HAS BROKEN IN THE BODY AT L4-5 LEVEL AND THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 WHERE REINFORCEMENT OF 3 RODS FOR THE BROKEN ROD WAS PERFORMED AT L3-S1. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2017. DURING REVISION SURGERY THERE WAS AN ERROR IN ORDERING ARRANGEMENTS AND THE MISSING PARTS WERE OVERLOOKED. THE CASE REQUIRED 2 OR MORE KITS, BUT OUT OF THE 2 KITS, THE ONE KIT HAD MISSING PARTS, AND IT WAS OVERLOOKED. FOR THE SURGERY, TWO 40 SIZES WERE REQUIRED, BUT THEY WERE SUBSTITUTED WITH SIZE 35 AND 50. 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 14159109 ↗
• InjuryMar 9, 2022Break; Break

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH STENOSIS FOR FUSI ON SPINAL THERAPY AT T9-L4. IT WAS REPORTED THAT RODS ON BOTH SIDES ARE BROKEN. THE SURGERY WAS PERFORMED ON THE (B)(6) 2022 AND THE RODS WERE REPLACED. THERE WAS HEALTH DAMAGE ON THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13708612 ↗
• InjuryMar 9, 2022Break; Break

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH STENOSIS FOR FUSI ON SPINAL THERAPY AT T9-L4. IT WAS REPORTED THAT RODS ON BOTH SIDES ARE BROKEN. THE SURGERY WAS PERFORMED ON THE (B)(6) 2022 AND THE RODS WERE REPLACED. THERE WAS HEALTH DAMAGE ON THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13708498 ↗