CD HORIZON® Spinal System 7577550Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885074032115), received between Mar 8, 2019 and Apr 15, 2026 — classified as 6 injuries, 3 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE TULIP HEADS WERE SEPARATED FROM THE THREADED SHANKS AND REVISION SURGERY WAS PERFORMED TO EXPLANT THE SEPARATED SCREWS. SCREW REVISION NEEDS TO BE DONE BY MINIMALLY INVASIVE PROCEDURE, BUT BECAUSE OF TULIP HEAD GOT SEPARATED OUT IT BECAME NECESSARY TO PERFORM OPEN SURGERY INSTEAD OF MIS. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887141 ↗
• InjuryApr 15, 2026Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE TULIP HEADS WERE SEPARATED FROM THE THREADED SHANKS AND REVISION SURGERY WAS PERFORMED TO EXPLANT THE SEPARATED SCREWS. SCREW REVISION NEEDS TO BE DONE BY MINIMALLY INVASIVE PROCEDURE, BUT BECAUSE OF TULIP HEAD GOT SEPARATED OUT IT BECAME NECESSARY TO PERFORM OPEN SURGERY INSTEAD OF MIS. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887119 ↗
• InjuryApr 15, 2026Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE TULIP HEADS WERE SEPARATED FROM THE THREADED SHANKS AND REVISION SURGERY WAS PERFORMED TO EXPLANT THE SEPARATED SCREWS. SCREW REVISION NEEDS TO BE DONE BY MINIMALLY INVASIVE PROCEDURE, BUT BECAUSE OF TULIP HEAD GOT SEPARATED OUT IT BECAME NECESSARY TO PERFORM OPEN SURGERY INSTEAD OF MIS. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887058 ↗
• MalfunctionAug 6, 2025Break; Product Quality Problem; Break; Product Quality Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A L 5-S1 MIS SPINAL FUSION PROCEDURE IN A PATIENT DIAGNOSED WITH DDD. IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR A FOLLOW-UP VISIT, THE PHYSICIAN DISCOVERED THAT THE HEAD AND SHANK OF OUR SCREW HAD SEPARATED. THE PHYSICIAN RAISED CONCERNS ABOUT THE RECENT QUALITY OF SCREWS. NO PLAN FOR ADDITIONAL SURGERY. 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 22727301 ↗
• MalfunctionAug 6, 2025Break; Product Quality Problem; Break; Product Quality Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A L 5-S1 MIS SPINAL FUSION PROCEDURE IN A PATIENT DIAGNOSED WITH DDD. IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR A FOLLOW-UP VISIT, THE PHYSICIAN DISCOVERED THAT THE HEAD AND SHANK OF OUR SCREW HAD SEPARATED. THE PHYSICIAN RAISED CONCERNS ABOUT THE RECENT QUALITY OF SCREWS. NO PLAN FOR ADDITIONAL SURGERY. 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 22727245 ↗
• InjuryJul 23, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4-S1 FUSION. P RE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS MYELOPATHY. IT WAS REPORTED THAT THE SCREW WAS BROKEN. NO FRAGMENT OF THE IMPLANT REMAINING IN THE PATIENT. PATIENT HAD PAIN IN THE BACK. THERE WERE NO OTHER PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE DISLOCATION HAPPENED AFTER THE INITIAL SURGERY. IT WAS FOUND DURING THE REVISION, WHICH WAS OPERATED DUE TO THE PATIENT¿S PAIN. THE DISLOCATION OF SCREW HAPPENED DURING THE INITIAL IMPLANTATION. AFTER WEEKS LATER PATIENT COMPLAINED OF PAIN AND THEY TOOK A X-RAY AND STILL DON¿T SEE THE DISLOCATION OF SCREW AND SCREW HEAD. IT WAS ALREADY DISLOCATED AND THE SCREW HEAD STILL STAYS ON TOP OF THE SCREW SHAFT HENCE IT WAS NOT ABLE TO BE DETECTED BY X-RAY. WHEN THEY OPEN UP THEY SEE THE SCREW HAD ALREADY DISLOCATED AND FROM THERE THEY REMOVED THE DISLOCATED SCREW AND REPLACE WITH A NEW ONE.

  Patient problems: Pain

  MAUDE report 19803807 ↗
• InjuryJun 17, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3-5 TLIF. IT WAS REPORTED THAT THE MULTI-AXIAL TULIP HEAD DISLOCATED FROM THE SCREW SHANK POST OP. THE REVISION SURGERY WAS PERFORMED TO REPLACE THE BROKEN HARDWARE ON (B)(6) 2022. 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 14727253 ↗
• InjuryJul 26, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SINGLE-LEVEL SPINAL SURGERY DUE TO SPONDYLOLISTHESIS WITH STENOSIS. POST-OP, THE IMPLANTED PEDICLE SCREW WAS BROKEN. ON (B)(6) 2019, THE PATIENT HAD UNDERWENT REVISION SURGERY DUE TO AN INFECTION. AT THIS REVISION, THE SURGEON IMPLANTED TWO NEW RODS AND NEEDED FOUR BREAK-OFF ITEMS. THE PEDICLE SCREWS REMAINED IN THE PATIENT. ON (B)(6) 2019, THE PATIENT GOT THE SECOND REVISION DUE TO THE SUSTAINED INFECTION OF THE PATIENT. WHEN THE SURGEON IMPLANTED THE CAGE FROM VENTRAL TO CHECK THE POSITION WITH X-RAY HE REMARKED THE BROKEN PEDICLE SCREW. THEY ROTATE THE PATIENT IN THIS SESSION AND REPLACED THE LEGACY SCREWS.

  Patient problems: Unspecified Infection

  MAUDE report 8829846 ↗
• MalfunctionMar 8, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINOPELVINE FIXATION SURGERY. POST-OPERATIVELY, AS THE SCREW WAS BEING EXPLANTED, THE SCREW WAS BROKEN IN THE UPPER PART. THE SHAFT FROM THE SCREW IS STILL IN THE PELVIC REGION OF THE PATIENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE PATIENT HAS ACHIEVED SOLID FUSION. NO PATIENT COMPLICATIONS WERE REPORTED. THE SCREW WAS BEING EXPLANTED SINCE THE PATIENT HAD ACHIEVED FUSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8402879 ↗