CD HORIZON® Spinal System 55840008570Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169004450), received between Dec 12, 2016 and Aug 22, 2017 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2017Failure to Align; Failure to Align

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: SCOLIOSIS LEVELS IMPLANTED: SACRUM IT WAS REPORTED THAT DURING SURGERY, THE SET SCREW COULD NOT BE ENTERED INTO THE SCREW HEAD. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6809458 ↗
• InjuryDec 12, 2016Break; Break

  PRE-OP DIAGNOSIS: DEGENERATIVE SPINAL DISEASE AND PREVIOUS T11-PELVIS FUSION ((B)(6) 2015) PROCEDURE: REVISION PELVIS SCREWS TO PREVIOUS T11-PELVIS FUSION LEVELS IMPLANTED: T11-PELVIS IT WAS REPORTED THAT POST-OP, DISTAL COMPONENT OF BROKEN SCREWS WERE TOO DEEP IN PELVIS TO BE REMOVED. MOVEMENT WAS VISIBLE DURING SURGERY AT S1/PELVIS JUNCTION. THE PATIENT SUFFERED FROM PAIN AND HENCE A REVISION FOR THE PELVIC SCREWS WAS DONE. FRAGMENTS OF THE PRODUCT REMAINED IN THE PATIENT AS DISTAL COMPONENT OF BROKEN SCREWS COULD NOT BE REMOVED BECAUSE THEY WERE TOO DEEP IN PELVIS TO BE REMOVED WITHOUT ADDITIONAL TRAUMA TO PATIENT.

  Patient problems: No Code Available; Pain

  MAUDE report 6165677 ↗
• InjuryDec 12, 2016Break; Break

  PRE-OP DIAGNOSIS: DEGENERATIVE SPINAL DISEASE AND PREVIOUS T11-PELVIS FUSION ((B)(6) 2015) PROCEDURE: REVISION PELVIS SCREWS TO PREVIOUS T11-PELVIS FUSION LEVELS IMPLANTED: T11-PELVIS IT WAS REPORTED THAT POST-OP, DISTAL COMPONENT OF BROKEN SCREWS WERE TOO DEEP IN PELVIS TO BE REMOVED. MOVEMENT WAS VISIBLE DURING SURGERY AT S1/PELVIS JUNCTION. THE PATIENT SUFFERED FROM PAIN AND HENCE A REVISION FOR THE PELVIC SCREWS WAS DONE. FRAGMENTS OF THE PRODUCT REMAINED IN THE PATIENT AS DISTAL COMPONENT OF BROKEN SCREWS COULD NOT BE REMOVED BECAUSE THEY WERE TOO DEEP IN PELVIS TO BE REMOVED WITHOUT ADDITIONAL TRAUMA TO PATIENT.

  Patient problems: No Code Available; Pain

  MAUDE report 6165676 ↗

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.