CD HORIZON® Spinal System 54840006550Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00613994579607), received between Oct 16, 2017 and Nov 4, 2025 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K091974); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TYPE OF ADDITIONAL SURGERY: REVISION DEVICE WAS DESTROYED AT THE FACILITY.

  Patient problems: Intervertebral Disc Compression or Protrusion; Pain; Spinal Cord Injury; Stenosis

  MAUDE report 23462213 ↗
• MalfunctionFeb 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICAL ID: (B)(4). IT WAS REPORTED THAT DURING AN INDEX SURGERY, THERE WAS A PULL OUT OF T12 SCREWS WITH POST JUNCTIONAL KYPHOSIS, LEADING TO HARDWARE FAILURE. AN X-RAY DIAGNOSTIC TEST CONFIRMED THE PULL OUT OF T12 SCREWS WHICH WAS CLINICALLY SIGNIFICANT. THE OUTCOME OF THIS ADVERSE EVENT WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER COMPLICATIONS REPORTED. SITE RELATED ASSESSMENT: ADVERSE EVENT PROBABLY RELATED TO THE INDEX SURGERY. NOT RELATED TO A MEDTRONIC CST DEVICE. SPONSOR ASSESSMENT: ASSESSMENT FOR PRODUCT/THERAPY/PROCEDURE RELATEDNESS MADE BY THE SPONSOR WAS DIFFERENT FROM INVESTIGATOR. THE ADVERSE EVENT WAS ASSESSED AS HAVING A CAUSAL RELATIONSHIP WITH THE INDEX SURGERY. AND HAD CAUSAL RELATIONSHIP WITH THE STUDY DEVICE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT AS PER THE DEVICE IDENTIFICATION CRF FOR THE SUBJECT, HOWEVER NO INDICATION OF SPECIFIC DEVICE RELATIONSHIP HAS BEEN MADE BY THE SITE. BASED ON THE NATURE OF THE EVENT, SPONSOR CHOSE A CONSERVATIVE ASSESSMENT OF DEVICE RELATED UNTIL IT CAN BE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21430284 ↗
• MalfunctionJan 2, 2025Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE THREADS OF SCREW STRIPPED OUT WHEN REDUCING THE ROD WITH SET SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21052545 ↗
• MalfunctionMay 20, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION, SCREW - ROD FIXATION AND TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERIES AT L4-S1. POST-OP, ONE OF THE SCREWS IMPLANTED IN S1 HAVE SEVERED AND WAS BROKEN. ON (B)(6) 2019 THE IMAGING WERE FINE AND SHOWED NO BREAKAGE. BUT ON (B)(6) 2020 THE IMAGING SHOWS ONE BROKEN SCREW AT S1. PATIENT IS AWARE AND THE SCREW REMAINS IN THE PATIENT'S BODY. NO INFORMATION ON ANY REVISION SURGERY HAS BEEN RECEIVED YET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10073647 ↗
• InjuryMar 10, 2020Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, POST-OP, THE IMPLANTED SCREW BROKE. HENCE, THE PATIENT UNDERWENT A REVISION LUMBAR SURGERY; AND THE BROKEN SCREW WAS EXPLANTED (AS PLANNED). EXTENSION OF FUSION WAS ALSO PERFORMED. PATIENT'S CONDITION AFTER THE REVISION SURGERY IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9812321 ↗
• InjuryFeb 26, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION AT L5-S1 DUE TO BACK PAIN. POST-OP, THE SCREWS WERE BROKEN. HENCE ON (B)(6) 2020, A REVISION SURGERY PERFORMED IN WHICH THE BROKEN SCREWS WERE REMOVED AND REPLACE THEM AND EXTEND FUSION TO THE ILEUM. NO OTHER PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9754420 ↗
• InjuryFeb 26, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION AT L5-S1 DUE TO BACK PAIN. POST-OP, THE SCREWS WERE BROKEN. HENCE ON (B)(6) 2020, A REVISION SURGERY PERFORMED IN WHICH THE BROKEN SCREWS WERE REMOVED AND REPLACE THEM AND EXTEND FUSION TO THE ILEUM. NO OTHER PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9754416 ↗
• InjuryFeb 20, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR FUSION DUE TO LEG/ BACK PAIN. POST-OP, SCREW BROKE OFF. AS A RESULT OF THIS EVENT REVISION SURGERY WAS PERFORMED TO EXPLANT THE BROKEN PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9731576 ↗
• InjuryOct 16, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION DUE TO STENOSIS, RADICULAR SYMPTOMS. POST-OP, ON (B)(6) 2017, THE SCREW ON THE LEFT SIDE AT S1 PEDICLE WAS REPORTED FOR BREAKAGE. PATIENT EXPRESSED PAIN AFTER SURGERY WITHOUT ANY TRAUMA INVOLVED. EXPLANT OF THE SAME HAS BEE PLANNED ON (B)(6) 2017.

  Patient problems: Pain

  MAUDE report 6950746 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091974. One submission often covers many models, so check the product and lot details in each record.

• Z-2876-2011 · Jun 28, 2011 · Terminated
  CD HORIZON (R) SOLERA (TM) FAS, REF 54410006035, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilizatio