CD HORIZON® Spinal System 25740018580Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169414914), received between May 14, 2019 and Jul 1, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION T9¿SAI FIXATION DUE TO ADULT SPINAL DEFORMITY. IT WAS REPORTED THAT THE LEFT SAISCREW BACKED OUT, THE ROD BECAME DETACHED, AND THE SET SCREW DISLODGED. A ROD FRACTURE WAS ALSO OBSERVED AT LEFT L3/4. THE SCREW HAD GRADUALLY BACKED OUT STARTING AROUND THE YEAR FOLLOWING THE INITIAL SURGERY. A REVISION SURGERY WAS PERFORMED ON JUNE 8 TO EXPLANT THE PRODUCTS. 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 25675391 ↗
• InjuryFeb 6, 2024Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A REVISION SURG ERY FOR PAIN DURING MOVEMENT. IT WAS REPORTED THAT THE LEFT PLUG (S2) DISLODGED AND THE RIGHT PLUG (S2) WAS LOOSE. SCREWS WERE LOOSE ON BOTH SIDES, LEFT F9.5-80MM, RIGHT F9.5-90MM AND WERE RE-INSTALLED. THE S1 PLUGS LOOSENED AND WAS REMOVED TOTALLY. THE PATIENT HAD PAIN DURING MOVEMENT, WAS RE-HOSPITALIZATED AND HAD A REPEAT SURGERY. THERE WAS NO OTHER PATIENT SYMPTOM REPORTED. THERE WERE NO F URTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18648517 ↗
• MalfunctionMar 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT WHICH IS USED IN POSTERIOR SPINAL FUSION FOR SCOLIOSIS CORRECTION SPINAL THERAPY FOR SCOLIOSIS. IT WAS REPORTED THAT THE SET SCREW APPEARS TO HAVE COME AWAY FROM THE BALLAST SCREWHEAD. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT IN THE FIRST FOLLOW UP, THE RIGHT SIDE ROD AND BALLAST SCREW HEAD NOT CONNECTED AND DURING 2ND FOLLOW UP APPOINTMENT, SET SCREW HAS COME AWAY FROM BALLAST SCREW HEAD. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO MALFUNCTION ASSOCIATED WITH THE ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535272 ↗
• InjuryDec 22, 2021Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE GUIDE WIRE GOT STUCK IN THE HOLLOW PART OF THE SCREW AND WHEN REMOVING IT, THE SCREW WAS REMOVED TOGETHER. IN THE S2 SACRAL FORAMEN PART, SCREW INSERTION MARK WAS FORMED. IN AN ADDITIONAL SURGERY THE SURGICAL PROCEDURE WAS CHANGED FROM S2AI TO ILIAC SCREW DURING THE SAME DAY . THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE IS ADULT SPINAL DEFORMITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057980 ↗
• MalfunctionFeb 26, 2020No Apparent Adverse Event; Migration; No Apparent Adverse Event; Migration

  INTRA-OP, THE SET SCREW HAD COME OFF FROM THE BALLAST SCREW PLACED ON THE CAUDAL SIDE. HENCE THE BALLAST SCREW IS EXPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9756057 ↗
• MalfunctionFeb 26, 2020No Apparent Adverse Event; Migration; No Apparent Adverse Event; Migration

  AS PER THE UPDATE RECEIVED, THERE IS NO ISSUE WITH THE REPORTED SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9756042 ↗
• InjuryMay 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR VERTEBRAL BODY REPLACEMENT SURGERY AND POSTERIOR FIXATION AT T4-S2AI DUE TO VERTEBRAL BODY COLLAPSE AT L4. ON AN UNKNOWN DATE, POST OP, SET SCREW ON THE CAUDAL SIDE TOTALLY BACKED OUT FROM THE SCREW HEAD AT S1/S2AI. SINCE ON ONE SIDE, THE DIRECTION OF THE SCREW HEAD AT S1 AND THE SCREW HEAD AT S2AI WERE DIFFERENT, IT WAS DIFFICULT TO HAVE BACK OUT ISSUE, BUT ALL THE FOUR SET SCREWS STILL BACKED OUT. THE PATIENT ALSO HAD PAIN IN THE LOWER BACK DUE TO SET SCREW BACKING OUT. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH SCREW REPLACEMENT AND FUSION FOR EXTENDING THE ROD WAS PERFORMED.

  Patient problems: Pain

  MAUDE report 8606820 ↗
• InjuryMay 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR VERTEBRAL BODY REPLACEMENT SURGERY AND POSTERIOR FIXATION AT T4-S2AI DUE TO VERTEBRAL BODY COLLAPSE AT L4. ON AN UNKNOWN DATE, POST OP, SET SCREW ON THE CAUDAL SIDE TOTALLY BACKED OUT FROM THE SCREW HEAD AT S1/S2AI. SINCE ON ONE SIDE, THE DIRECTION OF THE SCREW HEAD AT S1 AND THE SCREW HEAD AT S2AI WERE DIFFERENT, IT WAS DIFFICULT TO HAVE BACK OUT ISSUE, BUT ALL THE FOUR SET SCREWS STILL BACKED OUT. THE PATIENT ALSO HAD PAIN IN THE LOWER BACK DUE TO SET SCREW BACKING OUT. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH SCREW REPLACEMENT AND FUSION FOR EXTENDING THE ROD WAS PERFORMED.

  Patient problems: Pain

  MAUDE report 8606760 ↗