CD HORIZON® Spinal System 55890006545Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169058187), received between Feb 14, 2018 and May 18, 2022 — classified as 1 injury, 3 malfunctions.

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

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A SCREW USED FOR SPINAL SURGERY. PRE-OP DIAGNOSIS WAS LUMBAR DISC HERNIATION. THE PROCEDURE PERFORMED IN THE EVENT WAS LUMBAR INTERVERTEBRAL DISC HERNIATION, POSTERIOR DISC REMOVAL, AND POSTERIOR LUMBAR SCREW FIXATION. IT WAS REPORTED THAT INTRA-OPERATIVELY, SCREW PLUG SLIPPED. THE PRODUCT CAME IN CONTACT WITH PATIENT. THERE WAS NO DELAY IN THE OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14432946 ↗
• MalfunctionJun 29, 2021Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF LUMBAR DISC HERNIATION WITH SPONDYLOLISTHESIS INVOLVED IN SPINAL FUSION THERAPY. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE SCREW WAS A UNIVERSAL SCREW, AFTER IMPLANTATION, IT WAS FOUND THAT THE SCREW'S TIP COULD NOT BE ROTATED AND COULDN'T PASS THE ROD. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. PATIENT IS ALIVE AND NO INJURY. ON 2021-JUNE-07, RECEIVED ADDITIONAL INFORMATION THAT AFTER SCREW WAS IMPLANTED IN THE HUMAN BODY, IT WAS FOUND THAT THE SCREW TIP COULD NOT BE ROTATED, AND THE ROD COULD NOT BE INSERTED WHEN THE ROD WAS INSTALLED. THEREFORE, IT WAS REMOVED AND REPLACED WITH A NEW SCREW. AFTER TAKING IT OUT, IT WAS REPEATEDLY CONFIRMED THAT IT WAS NOT STUCK, BUT COULDN'T BE ROTATED. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12083603 ↗
• InjuryJul 3, 2020Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LENKE 1C THORACIC SCOLIOSIS; AND UNDERWENT A SURGERY AT T4-T12. AT THE 6 MONTH POST-OP FOLLOW-UP, EVERYTHING LOOKED FINE. AT 1 YEAR FOLLOW-UP, IT WAS NOTED THAT THE RIGHT ROD DISLOCATED FROM THE LOWER RIGHT SCREW, WHICH LIKELY CAUSED BREAKAGE OF THE LOWER LEFT SCREW. HENCE, ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH THE BROKEN SCREW WAS COMPLETELY EXPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10229434 ↗
• MalfunctionFeb 14, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  PRE-OPERATIVE DIAGNOSIS: TRAUMATIC KYPHOSIS. TYPE OF PROCEDURE: PSF (POSTERIOR SPINAL FUSION) LEVELS IMPLANTED: T11-L1. IT WAS REPORTED THAT ON POST-OP, THE LOWER SCREW OF CONSTRUCT WAS DISCONNECTED. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7270979 ↗

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.