CD HORIZON® Spinal System 7575540Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885074030630), received between Mar 3, 2017 and Mar 11, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Break; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING SCREWS USED FOR MIST TLIF PROCED URE USING THE SEXTANT SPONDY SYSTEM. IT WAS REPORTED THAT THE SCREWS HEAD PULLED OUT DURING LOADING ON THE TOWER AND TIGHTENING WITH THE SCREWDRIVER. THE PRODUCT WAS NOT IMPLANTED AND NO FRAGMENT REMAINED IN THE PATIENT. THE SCREW WAS CHANGED IMMEDIATELY. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WAS A UNDESIRED BREAKING OF THE SCREW TULIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566809 ↗
• MalfunctionMar 10, 2026Break; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING SCREWS USED FOR MIST TLIF PROCED URE USING THE SEXTANT SPONDY SYSTEM. IT WAS REPORTED THAT THE SCREWS HEAD PULLED OUT DURING LOADING ON THE TOWER AND TIGHTENING WITH THE SCREWDRIVER. THE PRODUCT WAS NOT IMPLANTED AND NO FRAGMENT REMAINED IN THE PATIENT. THE SCREW WAS CHANGED IMMEDIATELY. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WAS A UNDESIRED BREAKING OF THE SCREW TULIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556612 ↗
• InjuryAug 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIA GNOSIS FOR RADIOGRAPHY. PROCEDURE OR TECHNIQUE USED WAS MIS LOGITITUDEII SYSTEM. LEVELS IMPLANTED 4. IT WAS REPORTED THAT THE SCREW TULIP POPPED OUT AFTER THE SURGERY, REVISION SURGERY WAS PERFORMED FOR REMOVING OTHER SCREWS FROM THE CONSTRUCT SCREWS HEADS GOT DAMAGED, SO ALL SCREWS WERE REPLACED. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569740 ↗
• InjuryMar 3, 2017Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A SEXTANT SURGERY IN WHICH SCREWS WERE IMPLANTED AT L5-S1. POST-OP, THE SCREWS BROKE DUE TO WHICH THE PATIENT HAD BACK PAIN. ON (B)(6) 2017, A REVISION SURGERY WAS PERFORMED IN WHICH THE BROKEN SCREWS WERE REMOVED AND REPLACED WITH 2 NEW SCREWS.

  Patient problems: No Code Available; Pain

  MAUDE report 6375352 ↗
• InjuryMar 3, 2017Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A SEXTANT SURGERY IN WHICH SCREWS WERE IMPLANTED AT L5-S1. POST-OP, THE SCREWS BROKE DUE TO WHICH THE PATIENT HAD BACK PAIN. ON 07 FEB 2017, A REVISION SURGERY WAS PERFORMED IN WHICH THE BROKEN SCREWS WERE REMOVED AND REPLACED WITH 2 NEW SCREWS.

  Patient problems: No Code Available; Pain

  MAUDE report 6375347 ↗