CD HORIZON® Spinal System 7575545Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885074030678), received between Feb 8, 2019 and Mar 17, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PERCUTANEOUS TRANSPEDICULAR FIXATION SURGERY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSPEDICULAR FIXATION SURGERY WITH THE LONGITUDE EQUIPMENT. THE SURGERY BEGAN WITH THE STEPS INDICATED BY THE SURGICAL TECHNIQUE; 4 5.5 X 45MM SCREWS WERE PLACED WITHOUT ANY INCONVENIENCE, AFTER THIS THE BAR WAS MEASURED AND PLACED ON ONE OF THE SIDES, THE STOPS WERE PLACED AND COUNTER-TORQUED, AS INDICATED BY THE TECHNIQUE AND WITHOUT ANY COMPLICATIONS; WHEN IT WAS DOING COUNTER TORQUE ON THE OTHER SIDE ONE OF THE STOPS SOUNDED AS IF IT HAD ALREADY BROKEN BUT IT WAS NOT LIKE THAT, IT WAS TRIED TWO OTHER STOPS (WHICH WERE DAMAGED) WITHOUT SUCCESS AND DR. CELIS DECIDES THAT IT IS BETTER TO CHANGE THE SCREW SINCE HE STATES THAT IN PREVIOUS SURGERIES SOMETHING SIMILAR HAD HAPPENED TO HIM, THAT THE SCREW FAILED AND DAMAGED THE STOPS; THE BAR WAS REMOVED, THE SCREW THAT WAS PRESENTING THE FAILURE AND A 6.5 X 45MM SCREW WAS PLACED, THIS SCREW PULLED OUT, SO DR. CELIS DECIDED TO PLACE A 7.5 X 45MM SCREW AND IN THIS THE COUNTER-TORQUE WAS PERFORMED NO INCONVENIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619699 ↗
• MalfunctionJun 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGOING MIS SEXTANT II FOR SPONDYLOLISTHESIS. LEVELS IMPLANTED WERE L5-S1. IT WAS REPORTED THAT SCREW CAP AND SCREW SEPERATED AFTER SURGERY. OPERATION DATE WAS (B)(6) 2023 & FOLLOW UP DATE WAS (B)(6) 2023. FOLLOW UP X-RAY FOUND THE SCREW ON THE L5 RIGHT SIDE WAS SEPARATED. FRAGMENT OF THE IMPLANT REMAINING IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED DUE TO THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT NO REVISION SURGERY PLANNED TO EXTRACT BROKEN SCREW, BECAUSE PATIENT HAS NO SYMPTOMS AND DID NOT IMPACT SPINAL FUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17103060 ↗
• InjuryFeb 8, 2019Break; Break

  LEVELS IMPLANTED: L3-L4-L5 IT WAS REPORTED THAT POST-OP, PATIENT REPORTED CONTINUE BACK PAIN. HENCE THE DOCTOR DECIDED TO CONTINUE FUSION AT LOWER LEVEL SPINE (S1). DURING THE PROCEDURE DOCTOR FOUND THAT ONE OF THE L5 SCREW WAS BROKEN RIGHT IN THE MIDDLE OF THE SCREW BODY.

  Patient problems: Pain

  MAUDE report 8319354 ↗