CD HORIZON® Spinal System 7543645Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00721902857539), received between Jan 13, 2017 and Feb 10, 2021 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K031655); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2021Device Slipped; Mechanics Altered; Device Slipped; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF LUMBAR DISC HERNIATION IN NEED OF TLIF USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICES HAVE DAMAGED, APPEARED SLIPPERY AND COULD NOT BE LOCKED. AFTER SLIPPED APPEARED, THE DOCTOR REPLACED IT WITH OTHER SCREW AND SCREW PLUG TO COMPETE THE OPERATION. THERE WAS A DELAY OF LESS THAN 60 MINS REPORTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11306244 ↗
• InjuryDec 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL DEFORMITY CORRECTION FOR SPINAL THERAPY. IT WAS REPORTED THAT THE ROD DISLODGE, BOPFAILURE , REQUIRES REVISION SPINE SURGERY TO REFIX THE DISLODGE ROD. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE PATIENT IS DUE FOR REVISION SURGERY. SURGERY HAPPENED ON (B)(6) 2020 BUT WHEN EXACTLY DISLODGEMENT OF ROD HAPPENED, THAT IS DIFFICULT TO COMMENT. PATIENT WENT FOR THE X-RAY, REALIZED THAT ROD HAS CAME OUT SO EXACT DATE OF THE EVENT WILL NOT BE ABLE TO GET. SCREWS WERE EXPLANTED DURING THE REVISION SURGERY PERFORMED TO CORRECT THE DISLODGED ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10981665 ↗
• InjuryDec 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL DEFORMITY CORRECTION FOR SPINAL THERAPY. IT WAS REPORTED THAT THE ROD DISLODGE, BOP FAILURE, REQUIRES REVISION SPINE SURGERY TO REFIX THE DISLODGE ROD. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE PATIENT IS DUE FOR REVISION SURGERY. SURGERY HAPPENED ON (B)(6) 2020 BUT WHEN EXACTLY DISLODGEMENT OF ROD HAPPENED, THAT IS DIFFICULT TO COMMENT. PATIENT WENT FOR THE X-RAY, REALIZED THAT ROD HAS CAME OUT SO EXACT DATE OF THE EVENT WILL NOT BE ABLE TO GET. SCREWS WERE EXPLANTED DURING THE REVISION SURGERY PERFORMED TO CORRECT THE DISLODGED ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10981655 ↗
• InjuryApr 22, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-L5 DUE TO DEGENERATIVE DISC DISEASE AND SPON DYLOLISTHESIS AT L4-L5. DURING 11TH MONTH POST-OP, THE PATIENT ALMOST HAD A FALL AND FELT PAIN. AN X-RAY WAS PERFORMED WHICH REVEALED A BROKEN SCREW. NO FUSION WAS ACHIEVED AS WELL. SHE FELT THE SUDDEN JOLT AT HER BACK WHEN SHE ALMOST FELL FORWARD. SHE WAS ALSO INSTRUCTED TO AVOID THESE THINGS SUCH AS VIBRATION OR SUDDEN JOLT OR FLEXION AND EXTENSION MOVEMENTS. NO REVISION SURGERY HAS BEEN PERFORMED YET.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8536991 ↗
• InjuryApr 26, 2018Break; Break

  TYPE OF PROCEDURE: ARTHRODESYS L5-S1. LEVELS IMPLANTED: L5-S1. IT WAS REPORTED THAT POST-OP, THE IMPLANTED SCREW WAS FOUND BROKEN. THE BROKEN SCREW WAS EXPLANTED COMPLETELY. PATIENT COMPLICATIONS ASSOCIATED IN THIS EVENT WERE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7463691 ↗
• InjuryJan 13, 2017Break; Break

  T WAS REPORTED THAT PATIENT UNDERWENT SURGERY DUE TO LUMBAR DISC PROTRUSION IN WHICH SPINAL INSTRUMENTATION WAS IMPLANTED. POST-OP, AROUND THE MIDDLE OF (B)(6) 2016, ONE SCREW WAS FOUND BROKEN. PATIENT UNDERWENT REPLACEMENT SURGERY ON (B)(6) 2016 IN WHICH SCREWS WERE REPLACED WITH OTHER MANUFACTURER'S PRODUCTS.

  Patient problems: No Code Available

  MAUDE report 6248749 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031655. One submission often covers many models, so check the product and lot details in each record.

• Z-2874-2011 · Jun 28, 2011 · Terminated
  CD HORIZON (R) LEGACY (TM) FAS, REF 7542535, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization an