CD HORIZON® Spinal System 7576302Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994235596), received between Feb 28, 2018 and Feb 28, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionFeb 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPONDYLOLISTHESIS(L4-5), STENOSIS(L5-S1) AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-S1. DURING SURGERY, THE MULTI-LEVEL REDUCTION EXTENDERS WERE BEING USED TO PLACE SCREWS AT L4, L5, AND S1. WHILE REDUCING, THE L5 EXTENDER DISENGAGED FROM THE SADDLE OF THE SCREW. AT THIS POINT, A CANNULATED SCREWDRIVER WAS CONNECTED AND THE EXTENDER AND THE SCREW WERE REMOVED. REDUCTION CONTINUED UNTIL THE L4 EXTENDER DISENGAGED. AGAIN THE EXTENDER AND THE SCREW WERE REMOVED AND REPLACED IN THE L4 BODY. THE SURGEON THEN DECIDED NOT TO REDUCE THE L4 SCREW. THE ROD AND SET SCREWS WERE PLACED IN AN OPEN FASHION. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7302185 ↗
• MalfunctionFeb 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPONDYLOLISTHESIS(L4-5), STENOSIS(L5-S1) AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-S1. DURING SURGERY, THE MULTI-LEVEL REDUCTION EXTENDERS WERE BEING USED TO PLACE SCREWS AT L4, L5, AND S1. WHILE REDUCING, THE L5 EXTENDER DISENGAGED FROM THE SADDLE OF THE SCREW. AT THIS POINT, A CANNULATED SCREWDRIVER WAS CONNECTED AND THE EXTENDER AND THE SCREW WERE REMOVED. REDUCTION CONTINUED UNTIL THE L4 EXTENDER DISENGAGED. AGAIN THE EXTENDER AND THE SCREW WERE REMOVED AND REPLACED IN THE L4 BODY. THE SURGEON THEN DECIDED NOT TO REDUCE THE L4 SCREW. THE ROD AND SET SCREWS WERE PLACED IN AN OPEN FASHION. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7302180 ↗