CD HORIZON® Spinal System 1475501060Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994792716), received between Dec 22, 2017 and Jun 23, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AND DECOMPRESSION SURGERY AT L3-S1 DUE TO E XTENTION OF FUSION. POST-OP, THE ROD WAS BROKEN IN THE SADDLE OF THE SCREW. HENCE ON (B)(6) 2020, REVISION SURGERY PERFORMED FOR THE EXTENSION OF FUSION AND IMPLANTS WERE REMOVED. DUE TO MICRO MOVEMENTS OF THE BROKEN ROD, PATIENT CAUSED A BACK PAIN.

  Patient problems: Pain

  MAUDE report 10183100 ↗
• InjuryJun 23, 2020Break; Break

  PRE DIAGNOSIS: PATIENT ENDURED CONTINUOUS PAIN PROCEDURE PERFORMED: REMOVAL OF METAL LEVELS IMPLANTED: L4-S1 POST OP, ROD BROKE OFF IN SADDLE OF SCREW. PATIENT ENDURED CONTINUOUS PAIN. AS A RESULT OF THIS METAL WAS REMOVED FROM THE PATIENT BODY.

  Patient problems: Pain

  MAUDE report 10182885 ↗
• InjuryDec 22, 2017Break; Break

  IT WAS REPORTED THE PATIENT HAD A REVISION EXTENSION FUSION 1 LEVEL UP. POST-OP, ROD BROKE. PATIENT EXPERIENCED BACK PAIN AND WAS REFERRED TO A NEURO SURGEON. AFTER X RAYS, IT WAS CONFIRMED THAT A ROD HAD BROKEN AND THERE WAS NO BONY FUSION. REVISION SURGERY WAS PERFORMED TO EXPLANT THE ROD.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7141658 ↗

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.