CD HORIZON® Spinal System 7576550Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885074031170), received between Mar 30, 2017 and Sep 28, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding screws used in Transforaminal Lu mbar Interbody Fusion therapy detected in MRI. It was reported that the screws broke. 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 50911052 ↗
• MalfunctionDec 19, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION SPINAL THERAPY TO L1. IT WAS REPORTED THAT THE SEPARATION OF SCREW SHAFT AND HEAD ALONG WITH BREAKAGE WAS OBSERVED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847919 ↗
• InjuryJun 5, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE 1 LEVEL MIS TLIF ( TRANSFORAMINAL LUMBAR INTERBODY FUSION). IT WAS REPORTED THAT SCREW DISLOCATED. REVISION SURGERY WAS PREFORMED BY REPLACING THE DISLOCATED SCREW WITH A BIGGER DIAMETER. NO PATIENT SYMPTOMS REPORTED. NO FRAGMENTS OF THE IMPLANT REMAINING IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148021 ↗
• MalfunctionSep 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED. SCREW WAS SEPARATED FROM THE SHANK. PROCEDURE PERFORMED WAS OPEN TRANSFORAMINAL LUMBAR INTERBODY FUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20116801 ↗
• InjuryJul 28, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SCREW USED IN TLIF + PPF THERAPY FOR DDD (DEGENERATIVE DISC DISEASE). IT WAS REPORTED THAT THE SCREW BROKE. THE SCREW HEAD AND SHAFT WERE SEPARATED. THE RING PART IS BROKEN AND SEPARATED. THE OPERATION WAS DONE ON (B)(6) 2023 AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO REMOVE THE BROKEN SCREW AND INSERT A NEW SCREW. THERE WERE NO PATIENT SYMPTOMS. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17412445 ↗
• InjuryApr 3, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR SPONDYLODESIS WITH TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY AT L5-S1 DUE TO LUMBAR DISCOPATHY/SPONDYLISTHESIS. POST-OP, THE IMPLANTED SCREW WAS BROKEN AND DUE TO THIS LUMBAR IMPLANTED CAGE WAS SHIFTED TOWARD SPINAL CANAL. REVISION SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT; WHERE REMOVAL OF THE ALLEGED SCREW PERFORMED. NO FRAGMENTS OF THE IMPLANT REMAIN IN PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9919420 ↗
• InjuryMar 30, 2017Break; Break

  IT WAS REPORTED THAT PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS SPONDYLOLITHESIS (L5/S1). FOR WHICH PATIENT UNDERWENT, L5/S1 MINIMALLY INVASIVE FUSION USING SEXTANT REDUCTION AND CAPSTONE CAGE AT LEVELS L5/S1. ON AN UNKNOWN DATE, POST-OP, THE IMPLANTED SCREW BROKE. PATIENT EXPERIENCED PAIN DUE AS A RESULT OF BROKEN SCREW. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017. BOTH S1 SCREWS WERE REPLACED AND NEW RODS AND SET SCREWS HAVE BEEN IMPLANTED.

  Patient problems: No Code Available; Pain

  MAUDE report 6445202 ↗