CD HORIZON® Spinal System 1553200500Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00613994990709), received between Sep 20, 2019 and Feb 4, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (11 reports).

1 other recall cover devices cleared under the same FDA submission (K113174); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A 13 LEVEL TL SPINAL DEFORMITY CORRECTION PROCEDURE IN A PATIENT. IT WAS REPORTED THAT SURGEON COMPLETED THE DEFORMITY CORRECTION BY PLACING THE SCREWS AND RODS, BUT AFTER SOME DAYS, THE PATIENT AGAIN CAME FOR DIAGNOSIS WITH A PAIN. DURING EXAMINATION, HCP FOUND THAT THE RODS WERE BROKEN AND NEEDED TO BE REPLACED. THE PATIENT WAS ADMITTED FOR A REDO SURGERY TO REMOVE AND REPLACE BROKEN IMPLANT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 24256695 ↗
• InjuryFeb 4, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A 13 LEVEL TL SPINAL DEFORMITY CORRECTION PROCEDURE IN A PATIENT. IT WAS REPORTED THAT SURGEON COMPLETED THE DEFORMITY CORRECTION BY PLACING THE SCREWS AND RODS, BUT AFTER SOME DAYS, THE PATIENT AGAIN CAME FOR DIAGNOSIS WITH A PAIN. DURING EXAMINATION, HCP FOUND THAT THE RODS WERE BROKEN AND NEEDED TO BE REPLACED. THE PATIENT WAS ADMITTED FOR A REDO SURGERY TO REMOVE AND REPLACE BROKEN IMPLANT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 24256679 ↗
• InjuryJan 10, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING MULTI LEVEL THORACIC FIXATION/FUSION. IT WAS REPORTED THAT THE ROD FRACTURED IN THE MIDDLE OF CONSTRUCT. REVISION SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT AND THE BROKEN IMPLANT WAS REPLACED BY A NEW ONE. 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 21121879 ↗
• InjuryApr 13, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REVISION SURGERY FOR REPLACEMENT OF THE BROKEN ROD FOR THE GROWTH ROD PLACEMENT CASE. IT WAS REPORTED THAT THE ROD WAS BROKEN POST OPERATIVELY. ORIGINAL SURGERY WAS DONE ON (B)(6) 2022. A REVISION SURGERY WAS PERFORMED TO REPLACE THE BROKEN ROD. PRODUCT EXPLANTED AND WILL BE RETURNED FOR EVALUATION.  THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE WAS PLACING GROWTH ROD FOR DEFORMITY CASE OF 8YRS OLD CHILD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102815 ↗
• InjuryFeb 21, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A COMPETENT AUTHORITY, HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH FUSION OF LUMBAR AND LUMBOSACRAL SPINE USING POSTERIOR TECHNIQUE. FUSION OF POSTERIOR COLUMN OF THORACIC SPINE USING INSTRUMENTATION BY POSTERIOR APPROACH. EXTENSION OF TL FUSION. PLACEMENT OF T9-T11 PEDICLE SCREWS. REPLACEMENT OF T12, L1 PEDICLE SCREWS. IT WAS REPORTED THAT AFTER POST-OP NOTE, PT. REQUIRED EXTENSION OF CURRENT FUSION AND REPLACEMENT OF BROKEN HARDWARE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18745684 ↗
• MalfunctionFeb 7, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A D 12-S2 ILLIUM FIXATION IN A PATIENT. IT WAS REPORTED THAT THE LEFT ROD BROKE. THE ROD REMAINS IMPLANTED AND CURRENTLY NO REVISION SURGERY PLANNED. PATIENT IS HAVING PERSISTENT PAIN IN HER HIPS REQUIRING ANALGESICS ON A REGULAR BASIS. PATIENT GETS INTERMITTENT SI JOINT BLOCKS.

  Patient problems: Pain

  MAUDE report 18656470 ↗
• InjurySep 4, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST AN INITIAL GROWTH ROD PLACEMENT PROCEDURE IN A PATIENT. IT WAS REPORTED THAT AFTER THE INITIAL SURGERY, PATIENT HAD TO UNDERGO REVISION SURGERY 2 TIMES DUE TO ROD BREAKAGE AND BACK PAIN. ROD WAS PRICKING THE BACK OF THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 17675612 ↗
• InjuryMar 20, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING D4 TO L3 DEFORM ITY CORRECTION FOR AN INDICATION OF SCOLIOSIS. IT WAS REPORTED THAT THE ROD WAS BROKEN AND THE BROKEN ROD WAS EXPLANTED AND NEW ROD IS PLACED ON (B)(6) 2023. 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 16570745 ↗
• InjuryNov 18, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH A ROD FOR A LEVOSCOLIOSIS OF THORACOLUMBAR SPINE WITH INSTRUMENTED CORRECTION. IT WAS REPORTED THAT THE ROD BROKE AND WAS EXPLANTED. THERE WAS NO PATIENT HARM. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15822871 ↗
• InjurySep 23, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR LUMBAR FUSION AT LEVEL 6. IT WAS REPORTED THAT THE ROD BROKEN AFTER IMPLANTATION AND REPLACED WITH ANOTHER ROD IN NEXT 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 12517822 ↗
• InjurySep 20, 2019Break; Break

  IT WAS REPORTED THAT POST-OPERATIVELY, THE ROD IN THE S1 AREA HAD BROKEN. THE PATIENT UNDERWENT ANOTHER SURGERY FOR REMOVING THE BROKEN ROD AND PLACEMENT OF 5.5 DIAMETER TITANIUM RODS. THE OLD HARDWARE WAS REPLACED WITH NEW INSTRUMENTATION. THE PHYSICIAN USED THE O-ARM AND STEALTH TO PLACE 6.0 DIAMETER COBALT CHROME RODS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9097181 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113174. One submission often covers many models, so check the product and lot details in each record.

• Z-2603-2018 · Jul 9, 2018 · Terminated
  Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.