CD HORIZON® Spinal System 1555000500Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994990037), received between Apr 17, 2018 and Jan 5, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING GROWTH ROD EXTE NSION / REVISION FOR SCOLIOSIS. IT WAS REPORTED THAT ROD TO BE REPLACED DUE TO BREAKING INSITU. DURING PROCEDURE TO REPLACE ROD METALLOSIS WAS NOTED IN THE GROWTH ROD CONNECTOR SO IT WAS REPLACED WITH A NEW GROWTH CONNECTOR AND TITANIUM ROD. 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 18456631 ↗
• InjuryDec 20, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED IN A PATIENT POST A SCOLIOSIS CORRECTION PROCEDURE. IT WAS REPORTED THAT RODS BROKE TWICE IN THE PATIENT. THE RODS WERE EXPLANTED. 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 18361964 ↗
• InjuryJan 9, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THORACIC AND LUMBAR ARTHRODESIS. ON AN UNKNOWN DATE, POST-OP, THE ROD BROKE. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH A CONNECTOR WAS FIXED TO THE ROD; AND ANOTHER ROD WAS ALSO ADDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9571697 ↗
• InjuryNov 18, 2019Break; Break

  PATIENT GOT THE REVISION OR ON (B)(6) 2018 DUE TO AN EASING OF THE SACRUM ONE SCREWS ON BOTH SIDES. DURING THIS REVISION THE PATIENT GOT THICKER SCREWS IN THE SACRUM ONE. IN (B)(6) 2019 THE PATIENT GOT THE FOLLOWING BESIDES DISEASES: PULMONARY EDEMA, EPILEPSY ATTACK, INFARCT. NOW THE PATIENT GET TO THE HOSPITAL OF STRANGE NOISES DURING MOVEMENTS. ON (B)(6) 2019 THE PATIENT IS GOING TO GET THE REVISION DUE TO THE BROKEN RODS. THE SURGEON IS GOING TO LEAVE USE SIDE TO SIDE CONNECTORS THE BUILD A PARALLEL BRIDGE WITH A SHORTER ROD. THE SURGEON DON`T WANT THE OPEN THE PATIENT AGAIN COMPLETELY FROM SACRUM TO THE TOP SCREWS TO IMPLANT A NEW ROD DUE TO THE MANY BESIDES DISEASES OF THE PATIENT. THE SURGEON IMPLANTED ROD, CONNECTORS AND SET SCREWS. THE PHYSICIAN MADE THE REVISION OF THE BROKEN WINGS ON (B)(6). INSTEAD OF EXPLANTING THE BROKEN RODS DR. (B)(6) BUILD AN DIVERSION WITH SIDE-TO-SIDE CONNECTORS ON THE MEDIAL SIDE OF THE EXISTING CONSTRUCT.

  Patient problems: Discomfort

  MAUDE report 9334057 ↗
• InjuryNov 18, 2019Break; Break

  PATIENT GOT THE REVISION OR ON (B)(6) 2018 DUE TO AN EASING OF THE SACRUM ONE SCREWS ON BOTH SIDES. DURING THIS REVISION THE PATIENT GOT THICKER SCREWS IN THE SACRUM ONE. IN AUGUST 2019 THE PATIENT GOT THE FOLLOWING BESIDES DISEASES: PULMONARY EDEMA, EPILEPSY ATTACK, INFARCT. NOW THE PATIENT GET TO THE HOSPITAL OF STRANGE NOISES DURING MOVEMENTS. ON (B)(6) 2019 THE PATIENT IS GOING TO GET THE REVISION DUE TO THE BROKEN RODS. THE SURGEON IS GOING TO LEAVE USE SIDE TO SIDE CONNECTORS THE BUILD A PARALLEL BRIDGE WITH A SHORTER ROD. THE SURGEON DON`T WANT THE OPEN THE PATIENT AGAIN COMPLETELY FROM SACRUM TO THE TOP SCREWS TO IMPLANT A NEW ROD DUE TO THE MANY BESIDES DISEASES OF THE PATIENT. THE SURGEON IMPLANTED ROD, CONNECTORS AND SET SCREWS. THE PHYSICIAN MADE THE REVISION OF THE BROKEN WINGS ON 14TH OF NOVEMBER. INSTEAD OF EXPLANTING THE BROKEN RODS DR. HARTUNG BUILD AN DIVERSION WITH SIDE-TO-SIDE CONNECTORS ON THE MEDIAL SIDE OF THE EXISTING CONSTRUCT

  Patient problems: Discomfort

  MAUDE report 9333912 ↗
• InjuryJun 28, 2019Break; Break

  IT WAS REPORTED THAT IN (B)(6) 2017, THE PATIENT UNDERWENT DEGENERATIVE SCOLIOSIS SURGERY. POST-OP, THE IMPLANTED ROD BROKE. HENCE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019, IN WHICH THE BROKEN ROD WAS COMPLETELY REMOVED. NO FRAGMENT OF THE BROKEN ROD REMAINED INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8744937 ↗
• InjuryApr 17, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SCOLIOSIS AND BACK PAIN AND UNDERWENT SCOLIOSIS CORRECTION FROM T10 TO L5 AND LAMINECTOMY T12-L4. POST-OP, ROD BREAKAGE WAS OBSERVED AFTER PATIENT'S LATERAL BENDING MOVEMENT. PAIN WAS OBSERVED AS THE RESULT OF THE EVENT. BROKEN ROD REPLACEMENT WAS PERFORMED DUE TO THE EVENT. NO FRAGMENTS OF THE BROKEN PART REMAINED IN THE PATIENT.

  Patient problems: Pain

  MAUDE report 7438223 ↗

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.