CD HORIZON® Spinal System 54840007540Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994589309), received between Sep 7, 2018 and Mar 15, 2025 — classified as 1 injury, 5 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR FUSION FOR BILATERAL LEG PAIN. LEVELS IMPLANTED: LEFT S1 PATIENT MEDICAL HISTORY: SMOKING, HYPERTENSION, CORONARY ARTERY DISEASE, POLY NEROMPATHY, VENOUS INSUFFICIENCY IT WAS REPORTED THAT THE SCREW BREAKAGE OCCURRED JUST BELOW SCREW HEAD. THE SCREW SHAFT IS STILL IMPLANTED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE REVISION SURGERY WAS PERFORMED FOR HARDWARE REMOVAL. IT IS NOT KNOWN IF THE SCREW WAS ALREADY BROKEN OR BROKE ON REMOVAL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21613218 ↗
• InjuryNov 12, 2021Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING USE FOR A PATIENT UNDERGONE UNKNOWN SPINAL THERAPY. THE PRE-OP DIAGNOSIS WAS MENTIONED AS SPINAL STENOSIS. IT WAS REPORTED THAT, 2 SCREWS WERE BROKEN POST-OPERATIVELY. PATIENT HAD A SYMPTOM OF PAIN. REVISION SURGERY WAS PERFORMED TO EXPLANT THE BROKEN SCREW ON (B)(6) 2021. THERE WERE NO BROKEN FRAGMENTS OF SCREW REMAINED IN PATIENT. THE PROCEDURE OR TECHNIQUE USED DURING INITIAL SURGERY WAS CONVENTIONAL SCREW INSERTION METHOD AND THE LEVELS IMPLANTED WERE L5-S1. THE IMPLANT DATE OF REPORTED PRODUCT WAS UNKNOWN. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 12801782 ↗
• MalfunctionSep 17, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY DUE TO SPINAL INSTABILITY. INTRA-OP, UPON TRYING TO REMOVE THE SCREW IN THE S1 PEDICLE WHICH DIDN'T FUSE FROM THE PREVIOUS SURGERY, THE SCREW BROKE RIGHT UNDER THE TULIP HEAD. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9074363 ↗
• MalfunctionSep 7, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH RECURRENT SPINAL STENOSIS WITH RIGHT LEG PAIN, COMPRESSION OF CAUDA EQUINA, GRADE 2 SPONDYLOLISTHESIS AT L4-L5, SEVERE SPONDYLOSIS AT L5-S1, DEGENERATIVE SPONDYLOLISTHESIS, L4-L5, GRADE 2, PRIOR LAMINECTOMY AT L5 AND UNDERWENT REVISION OF A PRIOR L4-S1 FUSION. DURING REMOVAL OF THE IMPLANTED INSTRUMENTS, WHEN REMOVING THE SCREW, THE SHAFT OF THE SCREW COMPLETELY FRACTURED IN HALF DIRECTLY UNDER THE TULIP HEAD. IT WAS THEN LEFT WITH THE THREADED PORTION OF THE SCREW STILL INSIDE OF THE PATIENT AND THE TULIP HEAD WAS DETACHED. THE THREADED PORTION OF THE RIGHT L4 SCREW AND THE THREADED PORTION OF BOTH L5 SCREWS REMAIN INSIDE OF THE PATIENT. INSTRUMENTS WERE FOUND BROKEN. THE SCREW FRACTURES FIRST OCCURRED UPON REMOVING THE RIGHT L4 SCREW. THEN AFTER THAT FRACTURED, THERE WAS AN ATTEMPT TO REMOVE BROKEN SCREWS. 1-2 ADDITIONAL OPERATING HOURS ADDED TO THE SURGERY TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7854559 ↗
• MalfunctionSep 7, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH RECURRENT SPINAL STENOSIS WITH RIGHT LEG PAIN, COMPRESSION OF CAUDA EQUINA, GRADE 2 SPONDYLOLISTHESIS AT L4-L5, SEVERE SPONDYLOSIS AT L5-S1, DEGENERATIVE SPONDYLOLISTHESIS, L4-L5, GRADE 2, PRIOR LAMINECTOMY AT L5 AND UNDERWENT REVISION OF A PRIOR L4-S1 FUSION. DURING REMOVAL OF THE IMPLANTED INSTRUMENTS, WHEN REMOVING THE SCREW, THE SHAFT OF THE SCREW COMPLETELY FRACTURED IN HALF DIRECTLY UNDER THE TULIP HEAD.IT WAS THEN LEFT WITH THE THREADED PORTION OF THE SCREW STILL INSIDE OF THE PATIENT AND THE TULIP HEAD WAS DETACHED. THE THREADED PORTION OF THE RIGHT L4 SCREW AND THE THREADED PORTION OF BOTH L5 SCREWS REMAIN INSIDE OF THE PATIENT.INSTRUMENTS WERE FOUND BROKEN. THE SCREW FRACTURES FIRST OCCURRED UPON REMOVING THE RIGHT L4 SCREW. THEN AFTER THAT FRACTURED, THERE WAS AN ATTEMPT TO REMOVE BROKEN SCREWS. 1-2 ADDITIONAL OPERATING HOURS ADDED TO THE SURGERY TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7854557 ↗
• MalfunctionSep 7, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH RECURRENT SPINAL STENOSIS WITH RIGHT LEG PAIN, COMPRESSION OF CAUDA EQUINA, GRADE 2 SPONDYLOLISTHESIS AT L4-L5, SEVERE SPONDYLOSIS AT L5-S1, DEGENERATIVE SPONDYLOLISTHESIS, L4-L5, GRADE 2, PRIOR LAMINECTOMY AT L5 AND UNDERWENT REVISION OF A PRIOR L4-S1 FUSION. DURING REMOVAL OF THE IMPLANTED INSTRUMENTS, WHEN REMOVING THE SCREW, THE SHAFT OF THE SCREW COMPLETELY FRACTURED IN HALF DIRECTLY UNDER THE TULIP HEAD. IT WAS THEN LEFT WITH THE THREADED PORTION OF THE SCREW STILL INSIDE OF THE PATIENT AND THE TULIP HEAD WAS DETACHED. THE THREADED PORTION OF THE RIGHT L4 SCREW AND THE THREADED PORTION OF BOTH L5 SCREWS REMAIN INSIDE OF THE PATIENT. INSTRUMENTS WERE FOUND BROKEN. THE SCREW FRACTURES FIRST OCCURRED UPON REMOVING THE RIGHT L4 SCREW. THEN AFTER THAT FRACTURED, THERE WAS AN ATTEMPT TO REMOVE BROKEN SCREWS. 1-2 ADDITIONAL OPERATING HOURS ADDED TO THE SURGERY TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7854551 ↗

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